510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K863902Substantially Equivalent

Modified Sarns Membrane Oxygenator

3M Health Care, Sarns, Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863902 is the FDA 510(k) clearance record for MODIFIED SARNS MEMBRANE OXYGENATOR, a class II device, cleared for 3M Health Care, Sarns on under FDA product code DTX (Gas Control Unit, Cardiopulmonary Bypass). FDA records list 76 510(k) clearances for 3M Health Care, Sarns, from to . As of , FDA records show no recalls naming K863902.

Clearance record

Decision date
Received
(65 days to decision)
Product code
DTX Gas Control Unit, Cardiopulmonary Bypass
Regulation
21 CFR 870.4300
Device class
Class II
Review panel
Cardiovascular
Applicant
3M Health Care, Sarns 6200 Jackson Rd., Ann Arbor MI
Third party review
No

Clearances, product code DTX

Trailing 12 months

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

FDA records show no clearances under product code DTX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTX, 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