510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863593Substantially Equivalent

Sarns Safety Loop

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

K863593 is the FDA 510(k) clearance record for SARNS SAFETY LOOP, a class II device, cleared for 3M Health Care, Sarns on under FDA product code DWD (Suction Control, Intracardiac, Cardiopulmonary Bypass). FDA records list 76 510(k) clearances for 3M Health Care, Sarns, from to . As of , FDA records show no recalls naming K863593.

Clearance record

Decision date
Received
(64 days to decision)
Product code
DWD Suction Control, Intracardiac, Cardiopulmonary Bypass
Regulation
21 CFR 870.4430
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 DWD

Trailing 12 months

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

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