510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K031903Substantially Equivalent

Rapido Cut-Away Bleedback Control Valve (Bbcv), Model 7568

Boston Scientific Corporation, St Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031903 is the FDA 510(k) clearance record for RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568, a class II device, cleared for Guidant Corporation on under FDA product code DTZ (Oxygenator, Cardiopulmonary Bypass). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show one recall naming K031903.

Clearance record

Decision date
Received
(257 days to decision)
Product code
DTZ Oxygenator, Cardiopulmonary Bypass
Regulation
21 CFR 870.4350
Device class
Class II
Review panel
Cardiovascular
Applicant
Guidant Corporation 4100 Hamline Ave. N, St Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTZ

Trailing 12 months
5 clearances under product code DTZ in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DTZ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260