We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Bearpac Gets 510(k) Clearance Allowing At-Home Use for Pleural Effusion Drainage System

Bearpac Gets 510(k) Clearance Allowing At-Home Use for Pleural Effusion Drainage System

ClearanceStamp_Blue.gif
December 2, 2020

Bearpac Medical has received 510(k) marketing clearance from the FDA for its Passio Pump Drainage System for home-based delivery of pleural effusion therapy.

The Passio system, which is used to remove excess fluids around the lung, is comprised of a catheter, a handheld pump control and a disposable collection kit that holds the drained fluid.

A common condition that affects more than 200,000 individuals in the U.S. each year, pleural effusion occurs when fluid builds up between lung tissue and the chest due to poor pumping by the heart or inflammation.

View today's stories

Medical Devices Submissions and Approvals

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Vaccine needle

    Turkish Researchers Downgrade Sinovac’s COVID-19 Vaccine Efficacy Rate

  • Luminex logo

    Luminex Receives EUA for Expanded Respiratory Pathogen Panel, Clearing It for COVID-19

  • Acquires -Acquired

    Amgen to Buy Five Prime Therapeutics for $1.9 Billion

  • abbott-logo.gif

    Abbott Secures EUA for COVID-19 Combination Test

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing