Quest Vessel Catheter
FDA 510(k) K971928 · Quest Medical, Inc.
510(k) numberK971928
Submission
- Device name
- Quest Vessel Catheter
- Applicant
- Quest Medical, Inc.
Allen, TX, US - Received
- May 27, 1997
- Decision date
- November 6, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4210
- Specialty
- Cardiovascular
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Questions and answers
When was Quest Vessel Catheter cleared by the FDA?
Quest Vessel Catheter (K971928) received a 510(k) decision of Substantially Equivalent on November 6, 1997, 163 days after the submission was received.
What is the product code of K971928?
The FDA product code is DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4210.