510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K991102Substantially Equivalent

Copilot Bleedback Control Valve, Model 1003331

Boston Scientific Corporation, Temecula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991102 is the FDA 510(k) clearance record for COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331, a class II device, cleared for Guidant Corp. on under FDA product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show one recall naming K991102.

Clearance record

Decision date
Received
(69 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
Guidant Corp. 26531 Ynez Rd., Temecula CA
510(k) summary
Summary
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