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
K834134Substantially Equivalent

Sarns 8.0 Soft Arc Cannula

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

K834134 is the FDA 510(k) clearance record for SARNS 8.0 SOFT ARC CANNULA, a class II device, cleared for 3M Health Care, Sarns on under FDA product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass). FDA records list 76 510(k) clearances for 3M Health Care, Sarns, from to . As of , FDA records show one recall naming K834134.

Clearance record

Decision date
Received
(139 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
3M Health Care, Sarns 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DWF

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