510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K897039Substantially Equivalent

Sarns Miniprime Cardioplegia Set W/conducer(tm)

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

K897039 is the FDA 510(k) clearance record for SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM), a class II device, cleared for 3M Company on under FDA product code DTR (Heat-Exchanger, Cardiopulmonary Bypass). FDA records list 13 510(k) clearances for 3M Company, from to . As of , FDA records show one recall naming K897039.

Clearance record

Decision date
Received
(88 days to decision)
Product code
DTR Heat-Exchanger, Cardiopulmonary Bypass
Regulation
21 CFR 870.4240
Device class
Class II
Review panel
Cardiovascular
Applicant
3M Company 6200 Jackson Rd., Ann Arbor MI
Third party review
No

Clearances, product code DTR

Trailing 12 months
1 clearance under product code DTR in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DTR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260