OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO.— 510(k) K883613

Substantially Equivalent

Stierlen-Maquet AG

FDA 510(k) clearance K883613 for OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO., Substantially Equivalent on 1988-09-15. Applicant: Stierlen-Maquet AG.

Clearance details

Applicant: Stierlen-Maquet AG
Product code: Code GDC
Advisory panel: General, Plastic Surgery
Date received: 1988-08-22
Decision date: 1988-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Germany, GR

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Adverse events under product code GDC

product code GDC

Malfunction: 791
Total: 791

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.