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Quest Vessel Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K971928

by Quest Medical Inc

Identifiers

510(k) Number
K971928 FDA 510(k)
FDA Product Code
DWF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4210 FDA 510(k)
Regulation Number
870.4210 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Quest Vessel Catheter is a vascular cannula designed for use in cardiopulmonary bypass procedures. It features a tapered shaft with barbed or bulbous tips to secure vein grafts and a female luer fitting for saline syringe attachment, facilitating intraoperative testing and administration.

This device is intended for single-use in cardiovascular surgical settings, including operating rooms. It is classified as a Class II medical device under FDA product code DWF and was granted FDA 510(k) clearance in 1997. The catheter is non-sterile when supplied and must be sterilized prior to use, adhering to standard surgical sterilization protocols.

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: QUEST VESSEL CATHETER (K971928) — FDA 510 (k) | Innolitics, K971928 FDA 510(k) - QUEST VESSEL CATHETER | Quest Medical, Inc., fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Quest Medical Inc
FDA Applicant
Quest Medical, Inc.

Sources (1)

  • FDA 510(k) K971928 24 fields · synced Sep 19, 2026