FDA 510(k) Premarket Notification K160450: Pleurx Pleural Catheter System

Submission Details & Decision

Normalized public record details for 510(k) notification K160450.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K160450

Applicant / Sponsor

Care Fusion

Device Name

Pleurx Pleural Catheter System

Product Code

DWM

Decision Date

2016-10-31

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2016-02-18

Related Establishments / Registrations

C.R. BARD, INC. Registration: 1018233 View Registration
CAREFUSION 2200, INC. Registration: 1423507 View Registration
CAREFUSION 2200, INC. Registration: 1625685 View Registration
MERIT MEDICAL SYSTEMS, INC. Registration: 1721504 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
Terumo BCT STERILIZATION SERVICES, Inc. Registration: 1724474 View Registration
BARD PERIPHERAL VASCULAR, INC. Registration: 2020394 View Registration
Isomedix Operations, Inc. Registration: 2030624 View Registration
IMPERIAL TRADING LIMITED Registration: 3000268902 View Registration
INNOPEX LIMITED Registration: 3001124136 View Registration
C.R. BARD, INC. Registration: 3006082230 View Registration
Merit Medical Nederland BV Registration: 3006950086 View Registration
Synergy Health Sterilisation UK Ltd Registration: 3010155661 View Registration
ALLEVA MEDICAL (D.G.) LTD Registration: 3010308146 View Registration
SIGNA MEDICAL, INC. Registration: 3010419931 View Registration
TURNXON PRECISION CO., LTD Registration: 3011534620 View Registration
Merit Maquiladora Mexico, S. DE R.L. DE C.V. Registration: 3011642792 View Registration
Merit Medical Canada Ltd. Registration: 3012536737 View Registration
PFM Medical, Inc Registration: 3013666218 View Registration
NINGBO CHIBANDA IMP &EXP CO, LTD Registration: 3014437893 View Registration
Merit Medical Asia Company Limited Registration: 3015225571 View Registration
Merit Medical UK Limited Registration: 3015309643 View Registration
BEARPAC MEDICAL, LLC Registration: 3015715211 View Registration
VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. Registration: 3017210488 View Registration
PALM MEDICAL INTERNATIONAL BV Registration: 3030626857 View Registration
Merit Medical Australia Pty Ltd. Registration: 3033589330 View Registration
ROCKET MEDICAL PLC Registration: 9610632 View Registration
BARD REYNOSA S.A. DE C.V. Registration: 9617592 View Registration
CareFusion D.R. 203 Ltd. Registration: 9680904 View Registration

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.