510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854261Substantially Equivalent

Advanced Cardiovascular Systems Hemostatic Valves

Advanced Cardiovascular Systems, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854261 is the FDA 510(k) clearance record for ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES, a class II device, cleared for Advanced Cardiovascular Systems, Inc. on under FDA product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass). FDA records list 103 510(k) clearances for Advanced Cardiovascular Systems, Inc., from to . As of , FDA records show 2 recalls naming K854261.

Clearance record

Decision date
Received
(42 days to decision)
Product code
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Regulation
21 CFR 870.4290
Device class
Class II
Review panel
Cardiovascular
Applicant
Advanced Cardiovascular Systems, Inc. 1395 Charleston Rd., Mountain View CA
Third party review
No

Clearances, product code DTL

Trailing 12 months

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

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