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QuikPass Catheter

by Traverse Vascular, Inc.

510(k) K214106

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 NumberK214106 Date28 Jan 2022ClearedStatusActive

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  • Withdrawn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
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

QuikPass Catheter is a single-lumen, over-the-wire percutaneous catheter used by physicians to access coronary and peripheral vasculature. It facilitates guidewire placement/exchange and contrast media delivery.

The device is supplied as a Class 2 medical device with FDA 510(k) clearance under K214106, product code DQY. It is indicated for use in cardiovascular procedures, including venous stent procedures, to improve catheter function and reduce complications.

Questions

AI-generated answers, 28 Sep 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 QuikPass Catheter used for?

    The QuikPass Catheter is used by physicians to access coronary and peripheral vasculature, facilitating guidewire placement or exchange and delivery of contrast media during cardiovascular procedures, including venous stent procedures, to improve catheter function and reduce complications.

  • How is the QuikPass Catheter supplied and is it reusable?

    The QuikPass Catheter is supplied as a single-lumen, over-the-wire percutaneous catheter and is intended for single-use only; it is not designed for cleaning, sterilization, or reuse due to infection and material degradation risks.

  • What regulatory pathway was used for the QuikPass Catheter?

    The QuikPass Catheter received FDA 510(k) clearance under submission K214106, demonstrating substantial equivalence to a predicate device, and is classified as a Class 2 medical device with product code DQY.