QUEST VESSEL CATHETER— 510(k) K971928

Name: FDA 510(k) clearance K971928
Creator: U.S. Food and Drug Administration
Published: 1997-11-06

Substantially Equivalent

Quest Medical, Inc.

FDA 510(k) clearance K971928 for QUEST VESSEL CATHETER, Substantially Equivalent on 1997-11-06. Applicant: Quest Medical, Inc.. Device class: 2.

Clearance details

Applicant: Quest Medical, Inc.
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 1997-05-27
Decision date: 1997-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allen, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWF

view all

K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23
K250937 — Venous Return Cannulae2026-03-11
K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)2026-02-23
K253203 — Retrograde Coronary Sinus Perfusion Cannulae2026-02-19
K253671 — Dual Stage Venous Cannulae2026-01-30

More clearances from Quest Medical, Inc.

view all

K241058 — Lyka® PORT Needle Free Access Device (4170Y)2024-12-18
K213846 — Q2 Blood Administration Sets2022-06-05
K213588 — Q2 IV Administration Sets2022-06-02
K202672 — Precision Delivery Infusion Set2021-01-21
K201984 — MPS 3 ND Myocardial Protection System2020-11-20

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.