QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)— 510(k) K994274

Substantially Equivalent

Quest Medical, Inc.

FDA 510(k) clearance K994274 for QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB), Substantially Equivalent on 2000-05-31. Applicant: Quest Medical, Inc..

Clearance details

Applicant: Quest Medical, Inc.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1999-12-20
Decision date: 2000-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allen, TX, US

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Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.