VANGUARD REPROCESSED INFLATION DEVICES— 510(k) K012480

Substantially Equivalent

Vanguard Medical Concepts, Inc.

FDA 510(k) clearance K012480 for VANGUARD REPROCESSED INFLATION DEVICES, Substantially Equivalent on 2002-01-22. Applicant: Vanguard Medical Concepts, Inc..

Clearance details

Applicant: Vanguard Medical Concepts, Inc.
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 2001-08-02
Decision date: 2002-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakeland, FL, US

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Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

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.