510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101113Substantially Equivalent

Guardian II Nc Hemostasis Valve

Zerusa Limited, Galway, IE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101113 is the FDA 510(k) clearance record for GUARDIAN II NC HEMOSTASIS VALVE, a class II device, cleared for Zerusa Limited on under FDA product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass). FDA records list 4 510(k) clearances for Zerusa Limited, from to . As of , FDA records show 2 recalls naming K101113.

Clearance record

Decision date
Received
(30 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
Zerusa Limited 219-220 Business Innovation, Galway, IE
510(k) summary
Summary PDF
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