510(k) K130123— BASIC AND DOMINANT FLEX SUCTION PUMPS

Substantially Equivalent

Medela AG

Clearance details

Applicant: Medela AG
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 2013-01-17
Decision date: 2013-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dousman, WI, US

Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.