510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902845Substantially Equivalent

Gentle Header

Enhanced Perfusion Systems, Inc., Grass Lake MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902845 is the FDA 510(k) clearance record for GENTLE HEADER, a class II device, cleared for Enhanced Perfusion Systems, Inc. on under FDA product code DWE (Tubing, Pump, Cardiopulmonary Bypass). FDA records list one 510(k) clearance for Enhanced Perfusion Systems, Inc. As of , FDA records show no recalls naming K902845.

Clearance record

Decision date
Received
(158 days to decision)
Product code
DWE Tubing, Pump, Cardiopulmonary Bypass
Regulation
21 CFR 870.4390
Device class
Class II
Review panel
Cardiovascular
Applicant
Enhanced Perfusion Systems, Inc. P.O. Box 418, Grass Lake MI
Third party review
No

Clearances, product code DWE

Trailing 12 months

FDA records hold no clearances under product code DWE in the trailing twelve months.

FDA records show no clearances under product code DWE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260