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Fogarty Corkscrew Catheters - Fogarty Graft Thrombectomy Catheters

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233619

by Edwards Lifesciences

Identifiers

510(k) Number
K233619 FDA 510(k)
FDA Product Code
DXE FDA 510(k)
Models / Variants
Fogarty Corkscrew Catheters FDA 510(k)
Fogarty Graft Thrombectomy Catheters FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5150 FDA 510(k)
Regulation Number
870.5150 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Fogarty Corkscrew Catheters and Fogarty Graft Thrombectomy Catheters are embolic catheters designed for the mechanical removal of organized thrombus and adherent thrombotic material. These devices are classified as Class II medical devices under the FDA’s embolic catheter category and are intended for use in peripheral arterial vasculature, including both native vessels and synthetic grafts such as arteriovenous (AV) fistulas for dialysis access and iliofemoral bypass grafts.

These catheters are supplied as single-use, sterile devices and are regulated under FDA 510(k) clearance (K233619) with a traditional review process. They are intended for use in cardiovascular procedures and are available in various sizes and configurations as specified in the product codes. Storage and handling follow standard sterile medical device protocols, ensuring compatibility with clinical environments requiring precise thrombectomy interventions.

Frequently asked questions

What are Fogarty Corkscrew Catheters used for?

These catheters are designed for the mechanical removal of organized thrombus and adherent thrombotic material in peripheral arterial vasculature. This includes both native blood vessels and synthetic grafts, such as arteriovenous (AV) fistulas for dialysis access or iliofemoral bypass grafts. They are specifically engineered to clear blockages in these critical areas, improving blood flow and restoring vascular function.

Are Fogarty Corkscrew Catheters single-use or reusable?

These catheters are supplied as single-use, sterile devices. This ensures patient safety by preventing cross-contamination between procedures and maintains the integrity of the device for its intended clinical use. Single-use also aligns with standard sterile medical device protocols in cardiovascular interventions.

What sizes and configurations are available for Fogarty Graft Thrombectomy Catheters?

The Fogarty Graft Thrombectomy Catheters come in multiple sizes and configurations, as indicated by the various product codes (e.g., 1000138054, 3005747797, etc.). These variations allow clinicians to select the appropriate catheter size for different graft types and vascular diameters, ensuring effective thrombectomy in diverse procedural settings.

How should Fogarty Corkscrew Catheters be stored?

Storage follows standard sterile medical device protocols to maintain compatibility with clinical environments. This includes keeping the catheters in their original packaging until use, protecting them from contamination, and adhering to manufacturer guidelines for shelf life and handling. Proper storage ensures the device remains sterile and functional for its intended use.

What regulatory pathway applies to Fogarty Corkscrew Catheters?

These catheters are regulated under the FDA’s 510(k) clearance process (K233619) with a traditional review. They are classified as Class II medical devices under the embolic catheter category, reflecting their intended use in cardiovascular procedures. The clearance confirms they are substantially equivalent to a predicate device, ensuring their safety and effectiveness for thrombectomy applications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Clot management - Edwards Lifesciences, PDF Fogarty Corkscrew Catheter - Edwards Lifesciences, Fogarty™ Clot Management Solutions - BD, PDF Fogarty Corkscrew Catheter - Edwards Lifesciences, PDF Fogarty Clot Management Catheters

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Edwards Lifesciences

Sources (1)

  • FDA 510(k) K233619 24 fields · synced Oct 1, 2026