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

Name: FDA 510(k) clearance K914422
Creator: U.S. Food and Drug Administration
Published: 1991-12-18

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.. Device class: 2.

Clearance details

Applicant: Devices For Vascular Intervention, Inc.
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 1991-10-03
Decision date: 1991-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Devices For Vascular Intervention, Inc.

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K935929 — MICROTRACK1994-03-10
K920707 — HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER1992-11-23
K911678 — ROTATING HEMOSTATIC VALVE1991-07-12
K910205 — LP-60 LOW PRESSURE INFLATION DEVICE1991-02-25
K901601 — HOLLOW MOTOR DRIVE UNIT1990-07-06

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.