Stockert V172-28 Venous Femoral Cannula

FDA 510(k) K022321 · Stockert Instrumente GmbH

Substantially Equivalent

510(k) numberK022321

Submission

Device name
Stockert V172-28 Venous Femoral Cannula
Applicant
Stockert Instrumente GmbH
Arvada, CO, US
Received
July 17, 2002
Decision date
October 9, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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 Stockert V172-28 Venous Femoral Cannula cleared by the FDA?

Stockert V172-28 Venous Femoral Cannula (K022321) received a 510(k) decision of Substantially Equivalent on October 9, 2002, 84 days after the submission was received.

What is the product code of K022321?

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.