FDA 510(k), K201404, Passio Pump Drainage System
FDA 510(k), K201404, Passio Pump Drainage System
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510(K) Number: K201404
Device Name: Passio Pump Drainage System
Manufacturer: Bearpac Medical
Device Classification Name: Apparatus, Suction, Patient Care
Regulation Number: 870.5050
Classification Product Code: DWM
Date Received: 05/28/2020
Decision Date: 11/20/2020
Regulation Medical Specialty: Cardiovascular
Device Name: Passio Pump Drainage System
Manufacturer: Bearpac Medical
Device Classification Name: Apparatus, Suction, Patient Care
Regulation Number: 870.5050
Classification Product Code: DWM
Date Received: 05/28/2020
Decision Date: 11/20/2020
Regulation Medical Specialty: Cardiovascular
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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