RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568— 510(k) K031903

Substantially Equivalent

Guidant Corporation

FDA 510(k) clearance K031903 for RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568, Substantially Equivalent on 2004-03-03. Applicant: Guidant Corporation.

Clearance details

Applicant: Guidant Corporation
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2003-06-20
Decision date: 2004-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St Paul, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTZ

product code DTZ

Death: 182
Injury: 422
Malfunction: 3,636
Total: 4,240

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.