VOLISTA 400; VOLISTA 600— 510(k) K130513

Substantially Equivalent

Maquet S.A.S.

FDA 510(k) clearance K130513 for VOLISTA 400; VOLISTA 600, Substantially Equivalent on 2013-05-08. Applicant: Maquet S.A.S..

Clearance details

Applicant: Maquet S.A.S.
Product code: Code FTD
Advisory panel: General, Plastic Surgery
Date received: 2013-02-27
Decision date: 2013-05-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Wayne, NJ, US

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Adverse events under product code FTD

product code FTD

Malfunction: 767
Total: 767

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.