COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331— 510(k) K991102

Substantially Equivalent

Guidant Corp.

FDA 510(k) clearance K991102 for COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331, Substantially Equivalent on 1999-06-09. Applicant: Guidant Corp..

Clearance details

Applicant: Guidant Corp.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1999-04-01
Decision date: 1999-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.