ANGIOPLASTY INFLATOR— 510(k) K911295

Substantially Equivalent

Vastek

FDA 510(k) clearance K911295 for ANGIOPLASTY INFLATOR, Substantially Equivalent on 1991-07-12. Applicant: Vastek.

Clearance details

Applicant: Vastek
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 1991-03-25
Decision date: 1991-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, OH, 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.