510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061772Substantially Equivalent

Triactiv Fx Embolic Protection System

DSM Biomedical, Inc., Exton PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061772 is the FDA 510(k) clearance record for TRIACTIV FX EMBOLIC PROTECTION SYSTEM, a class II device, cleared for Kensey Nash Corp. on under FDA product code NFA (Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection). FDA records list 54 510(k) clearances for DSM Biomedical, Inc., from to . As of , FDA records show 3 recalls naming K061772.

Clearance record

Decision date
Received
(18 days to decision)
Product code
NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Kensey Nash Corp. 735 Pennsylvania Ave., Exton PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFA

Trailing 12 months

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

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