MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057— 510(k) K021368

Substantially Equivalent

Medela AG

FDA 510(k) clearance K021368 for MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057, Substantially Equivalent on 2002-05-15. Applicant: Medela AG.

Clearance details

Applicant: Medela AG
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 2002-04-30
Decision date: 2002-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ch-6340 Baar, CH

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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.