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HYPERTRANSIT Infusion Catheter

by Cordis Neurovascular, Inc.

510(k) K043538

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK043538 Date18 Apr 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KRA
Device Class
Class II
Regulation
21 CFR Part 870.1210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The HYPERTRANSIT Infusion Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. It is intended for infusion of therapeutic agents in the coronary and peripheral vasculature. The catheter features a hydrophilic coating for lubricity during vessel navigation and an inner lumen lined with PTFE to facilitate movement of guidewires and other devices.

The catheter body is radiopaque to aid visualization. It is supplied as a single-use device and requires storage according to the manufacturer's instructions. The device has received FDA 510(k) clearance with product code KRA and regulation number 870.1210.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the HYPERTRANSIT Infusion Catheter designed for?

    The HYPERTRANSIT Infusion Catheter is designed to access small, tortuous vasculature for infusion of therapeutic agents in the coronary and peripheral vasculature. It features a variable stiffness design to navigate challenging anatomies.

  • How is the HYPERTRANSIT Infusion Catheter supplied and what are its storage requirements?

    The HYPERTRANSIT Infusion Catheter is supplied as a single-use device and must be stored according to the manufacturer's instructions. It is not intended for reuse and should be discarded after a single procedure.

  • What special features does the HYPERTRANSIT Infusion Catheter have?

    The catheter features a hydrophilic coating for enhanced lubricity during vessel navigation and an inner lumen lined with PTFE to facilitate movement of guidewires and other devices. It also has a radiopaque body to aid visualization during procedures.

  • What is the regulatory status of the HYPERTRANSIT Infusion Catheter?

    The HYPERTRANSIT Infusion Catheter has received FDA 510(k) clearance with product code KRA and regulation number 870.1210. It is classified as a Class II device and is substantially equivalent to other devices on the market.