510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K932208Substantially Equivalent

Extracorporeal Circuit W/duraflo II Heparin Treatm

Baxter Healthcare Corporation, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932208 is the FDA 510(k) clearance record for EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM, a class II device, cleared for Baxter Healthcare Corp on under FDA product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K932208.

Clearance record

Decision date
Received
(460 days to decision)
Product code
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Regulation
21 CFR 870.4210
Device class
Class II
Review panel
Cardiovascular
Applicant
Baxter Healthcare Corp P.O. Box 19522, Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code DWF

Trailing 12 months
8 clearances under product code DWF in the twelve months to November 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DWF, trailing twelve months
MonthClearances
December 20250
January 20262
February 20262
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20261
November 20260