Passio Pump Drainage System— 510(k) K190292

Substantially Equivalent

Bearpac Medical

FDA 510(k) clearance K190292 for Passio Pump Drainage System, Substantially Equivalent on 2019-07-25. Applicant: Bearpac Medical.

Clearance details

Applicant: Bearpac Medical
Product code: Code DWM
Advisory panel: Cardiovascular
Date received: 2019-02-11
Decision date: 2019-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moultonborough, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWM

product code DWM

Death: 8
Total: 8

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.