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FDA 510(k)

Passio Pump Drainage System

K-Number: K190292 · 2019-07-25

ApplicantBearpac Medical
Decision Date2019-07-25
Product CodeDWM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Passio Pump Drainage System is a medical device manufactured by Bearpac Medical. It received FDA 510(k) clearance on 2019-07-25 under approval number K190292. 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 2019-07-25. It is manufactured by Bearpac Medical. The 510(k) number is K190292.

When was Passio Pump Drainage System approved by the FDA?

Passio Pump Drainage System received FDA 510(k) clearance on 2019-07-25, under approval number K190292.

What company makes Passio Pump Drainage System?

Passio Pump Drainage System is manufactured by Bearpac Medical.

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

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

Related Clinical Trials

NCT07603531 Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema NOT_YET_RECRUITING NCT06201429 A Multi-center, Early Feasibility Study of Using the Mechanical Tissue Resuscitation™ (MTR®) Therapy System for Removal of Excess Fluid in Subjects Who Have Had a Portion of Their Skull Removed to Expose the Dura/Brain and Require Drainage for Fluid Removal. RECRUITING NCT07494812 Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials NOT_YET_RECRUITING NCT07527702 Low (-4) vs Physiologic (-8) Pressure Digital Continuous Suction After Lung Resection RECRUITING NCT05511987 Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients RECRUITING

Other Devices by Bearpac Medical

K201404Passio Pump Drainage System K230319Passio Pump Drainage System

Related Devices (Code: DWM)

K160450Pleurx Pleural Catheter SystemCare Fusion K163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical Plc K201404Passio Pump Drainage SystemBearpac Medical K210509Rocket Platinum Cured CathterRocket Medical Plc K212696Aspira Pleural Drainage SystemMerit Medical Systems, Inc.

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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