DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVE— 510(k) K914422

Substantially Equivalent

Devices For Vascular Intervention, Inc.

FDA 510(k) clearance K914422 for DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVE, Substantially Equivalent on 1991-12-18. Applicant: Devices For Vascular Intervention, Inc..

Clearance details

Applicant: Devices For Vascular Intervention, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 1991-10-03
Decision date: 1991-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.