Passio Pump Drainage System

FDA 510(k) K190292 · Bearpac Medical

Substantially Equivalent

510(k) numberK190292

Submission

Device name
Passio Pump Drainage System
Applicant
Bearpac Medical
Moultonborough, NH, US
Received
February 11, 2019
Decision date
July 25, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DWM – Apparatus, Suction, Patient Care
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5050
Specialty
Cardiovascular

Other 510(k)s with product code DWM

510(k)DeviceApplicantDecision
K212696Aspira Pleural Drainage SystemDWM · Traditional Merit Medical Systems, Inc.03/03/2023SE
K210509Rocket Platinum Cured CathterDWM · Traditional Rocket Medical Plc09/09/2021SESK
K201404Passio Pump Drainage SystemDWM · Traditional Bearpac Medical11/20/2020SE
K163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitDWM · Traditional Rocket Medical Plc08/17/2017SE
K160450Pleurx Pleural Catheter SystemDWM · Traditional Care Fusion10/31/2016SE
K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitDWM · Traditional Care Fusion07/02/2015SE
K123033Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and…DWM · Traditional Rocket Medical Plc02/01/2013SE
K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…DWM · Traditional Care Fusion10/18/2012SE
K112831Pleurx Pleural Catheter SystemsDWM · Traditional Care Fusion02/16/2012SE
K110409Aspira Pleural Drainage SystemDWM · Special C.R. Bard, Inc.05/11/2011SE

More from C.R. Bard, Inc.

510(k)DeviceDecision
K230319Passio Pump Drainage SystemPNG · Traditional 11/24/2023SESK
K201404Passio Pump Drainage SystemDWM · Traditional 11/20/2020SE

Questions and answers

When was Passio Pump Drainage System cleared by the FDA?

Passio Pump Drainage System (K190292) received a 510(k) decision of Substantially Equivalent on July 25, 2019, 164 days after the submission was received.

What is the product code of K190292?

The FDA product code is DWM – Apparatus, Suction, Patient Care, a Class II (moderate risk) device regulated under 21 CFR 870.5050.