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FDA 510(k)

Passio Pump Drainage System

K-Number: K201404 · 2020-11-20

ApplicantBearpac Medical
Decision Date2020-11-20
Product CodeDWM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Passio Pump Drainage System is the device name listed in this FDA 510(k) record. The listed applicant is Bearpac Medical. It received FDA 510(k) clearance on 2020-11-20 under 510(k) number K201404. The device is classified under product code DWM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Passio Pump Drainage System?

Passio Pump Drainage System is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Bearpac Medical. The 510(k) number is K201404.

When did Passio Pump Drainage System receive FDA 510(k) clearance?

Passio Pump Drainage System received FDA 510(k) clearance on 2020-11-20, under 510(k) number K201404.

Who is the listed applicant for Passio Pump Drainage System?

The FDA 510(k) record lists Bearpac Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Passio Pump Drainage System?

The FDA product code for Passio Pump Drainage System is DWM.

Other records listing Bearpac Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230319Passio Pump Drainage SystemK190292Passio Pump Drainage System

Related Devices (Code: DWM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212696Aspira Pleural Drainage SystemMerit Medical Systems, Inc.K210509Rocket Platinum Cured CathterRocket Medical PlcK190292Passio Pump Drainage SystemBearpac MedicalK163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical PlcK160450Pleurx Pleural Catheter SystemCare Fusion

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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