ACIER SUTURES— 510(k) K991073

Substantially Equivalent

Cardio Thoracic Systems

FDA 510(k) clearance K991073 for ACIER SUTURES, Substantially Equivalent on 1999-07-30. Applicant: Cardio Thoracic Systems.

Clearance details

Applicant: Cardio Thoracic Systems
Product code: Code GAQ
Advisory panel: General, Plastic Surgery
Date received: 1999-03-31
Decision date: 1999-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

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Adverse events under product code GAQ

product code GAQ

Death: 3
Malfunction: 522
Total: 525

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.