15
FDA 510(k) Clearances
Design & Development
Catalyst by Cordica Medical. The faster path from first idea to 510(k).
Catalyst is the entry point to Cordica Medical's fully integrated medical device platform. From first concept through device engineering, component development, and commercial-scale production. One integrated team accelerates your path from innovation to market.
Catalyst: Your Device, Designed to be built
Design and manufacturing working as one. Not in sequence.
Catalyst is Cordica's innovation, engineering, DfM, and regulatory engine, transforming clinical ideas into cleared, manufacturable devices faster. Cordica Medical brings added engineering depth, materials science expertise, and commercial-scale production capabilities. One integrated platform, from the physician's idea to the finished device.
Design
From ideation to clinical concept and requirements through human factors and engineering. Every discipline in one team.
Develop
From prototype through clinical builds, verification & validation execution, and design freeze. Each stage brings your device closer to submission-ready.
Manufacture
Process validation, manufacturing tooling, regulatory filings, and full-scale production, within the organization that designed your device.
Catalyst: Engineering Capabilities
Every engineering discipline your program requires.
Catalyst’s engineering team, part of Cordica Medical’s fully integrated medical device platform, covers all disciplines needed to take a medical device from concept to commercialization.
Catalyst: What We Build
Specialized capabilities. Proven across complex programs.
From precision extrusion and braiding to electrospinning nanofibers and micro-molding, Catalyst by Cordica brings specialized manufacturing capability into the design and development process from day one.
Catalyst: Track Record
Cleared. Delivered. Proven.
15 FDA 510K Clearances
10 years
6 Therapeutic Areas
2026 | Endoscopy
Transnasal Endoscope, Pediatric
2025 | Endoscopy X2
Transnasal Endoscope, Pediatric
2025 | Surgical
Line of Laser Fibers
2025 | GI/Endoscopy
Biliary Endoscopy System
2022 | Endoscopy
Transnasal Endoscope, Pediatric
2021 | Electrophysiology
RF Transeptal Puncture Device
2021 | Vascular
Arterial/Venous Thromboembolism Treatment Device
2019 | Vascular x 3
Arterial/Venous Thromboembolism Treatment Device
2018 | Drug Delivery
Fluid Transfer Connector (ISO 80369-7)
2017 | Drug Delivery
Tamper Evident Cap for Enteral (ENFit) Syringes
Catheter & Materials Engineering
Material science and catheter engineering. Fully integrated.
Cordica Medical's catheter development platform is vertically integrated, with materials engineered and extruded in-house and custom prototype tubing available within 5 business days.
Catalyst: Markets & Products
Your market. One partner.
Catalyst by Cordica Medical's catheter engineering platform serves interventional cardiovascular, neurovascular, electrophysiology, robotic surgery, gastrointestinal, and endoscopy markets from concept through commercial production.
TAVR/TMVR/TTVR delivery systems Structural heart access systems Balloon catheters Steerable sheaths Coronary diagnostic and therapeutic catheters Peripheral vascular catheters Renal denervation catheter systems
Thrombectomy and aspiration catheters Microcatheters Intermediate and distal access catheters Coil and flow diverter delivery systems Neuro guide catheters
Multi-lumen catheter shaft systems Deflectable and steerable catheter systems Steerable sheath systems RF transeptal puncture systems Mapping catheter shafts Ablation catheter shafts Lasso and circular mapping catheters
Flexible robotic catheter shafts Flexible robotic catheter shafts Sensor-integrated components Robotic-compatible introducers
Transnasal endoscopes Biliary endoscopy systems Pediatric endoscopy systems Endoscope shafts and components
Access sheaths PICC and CVC systems Drainage catheters Introducer systems
Infusion delivery catheters Drug delivery connectors Enteral connectors and components Combination product device components Delivery system catheter shafts
Minimally invasive surgical devices Glaucoma treatment systems
Interventional Cardiovascular
TAVR/TMVR/TTVR delivery systems Structural heart access systems Balloon catheters Steerable sheaths Coronary diagnostic and therapeutic catheters Peripheral vascular catheters Renal denervation catheter systems
Devices Across A Spectrum Of Therapeutic Areas
From complex interventional systems and catheter-based delivery platforms to critical care flexible products, drug delivery, and custom automation, Cordica Medical engineers and manufactures medical devices across a spectrum of therapeutic areas.
Converting & Flexible Product Development
Where material science becomes device performance.
At Cordica Medical, converting is a design discipline, not a manufacturing step. Our engineers specify laminate architecture from material science principles, including adhesive system, coat weight, membrane layer performance, release liner behavior, and die geometry. Every layer is specified with the finished device performance in mind.
- Wound dressing architecture: foam, hydrocolloid, backing film, silicone skin contact layer, release liner.
- NPWT: High-absorbency component development for negative pressure wound therapy systems.
- Wearable Substrates: CGM cover tapes, cardiac monitoring patches, and pulse oximetry substrates.
- Lateral Flow: Laminate architecture and microfluidic layer design for diagnostic assay platforms.
- IVD Converting: Cover tape and sealing film development for in-vitro diagnostic consumables.
- Transdermal: Adhesive coat weight specification, membrane layer design, and island placement architecture.
- Pharma Packaging: Drug delivery component design, 21 CFR 280 compliant manufacturing development.
- Textile Engineering: RF welding, ultrasonic welding, and sewing construction for soft goods and flexible devices.
- Compression: Performance architecture for DVT garments, orthotics, and compression systems.
- Cleanroom Converting: Laminating in FDA-registered, ISO 13485-certified facilities across the US.
- Dry Room Assembly: ESD-controlled development for electronics-adjacent wearable and diagnostic applications.
- Precision die cutting process development: rotary, steel rule, matched-metal, cleanroom, and digital laser/CNC
- Multi-web lamination process qualification: inline laminating, slitting, and island placement
- Clean & FDA-registered: ISO 13485-certified facilities in California, Massachusetts, and Singapore
- AI vision system & in-line optical inspection: process development for high-volume quality programs
- Advanced Wound Care: dressings, NPWT components, antimicrobial constructions, hydrocolloid and foam platforms
- Diagnostics: lateral flow assays, microfluidics, IVD consumables, diagnostic cover tapes
- Patient Monitoring and Wearables: CGM substrates, cardiac monitoring, pulse oximetry, pacemaker components
- Patient Mobility and Recovery: compression devices, DVT garments, orthotics, braces, tourniquets
- Infection Control: catheter securement, antiseptic film constructions, wound protection
- Drug Delivery Interfaces: transdermal patch development, pharma packaging component design
Automation & Manufacturing System Design
Custom automation. Engineered for your program.
Cordica Medical combines purpose-built and best-in-class production equipment, engineering custom automation where it matters most. Our in-house teams design, build, and validate systems in parallel with the device, so your project doesn't stall.
- Custom automation cell design and build for device-specific assembly
- Robotic assembly with integrated 100% in-line vision inspection
- AI vision system development for high-volume quality control
- In-house fatigue testing systems validated for FDA structural heart submissions
- Pilot line design mirroring commercial production architecture
Global Quality & Regulatory
Regulatory embedded from day one.
Every program at Cordica Medical operates within an ISO 13485-certified Quality Management System. Regulatory strategy is embedded from the first design review, not added at the time of submission.
Quality System Credentials
- ISO 13485 certified across many Cordica facilities
- FDA registered across 9 manufacturing locations
- MDSAP certified where applicable
- 21 CFR 210-211 compliant for pharma packaging and kitting applications
Regulatory Support
- FDA Q-Sub engagement from concept stage
- Design History File (DHF)/Medical Device File (MDF) management throughout the program
- Risk management from initial hazard analysis through post-market surveillance
- 510(k) preparation and regulatory filing support
Tell us about your device. Our engineers will take it from there.
Whether you have a clinical concept without an engineering team, an existing design that needs a manufacturing path, or a program that needs a new production partner, we have the right practice for you. Let us know your stage, and our engineering team will respond promptly.
Build with Cordica