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510(k) K112831

Device
PLEURX PLEURAL CATHETER SYSTEMS
Applicant
CAREFUSION
510(k) number
K112831
Product code
DWM  
Decision
Substantially Equivalent (SESE)
Decision date
2012-02-16
Date received
2011-09-28
Regulation
870.5050
Classification name
Apparatus, Suction, Patient Care
Medical specialty
Cardiovascular
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOY GREIDANUS
Address
1500 Waukegan Rd. Waukegan IL US 60085 60085

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DWM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K212696Aspira Pleural Drainage SystemMerit Medical Systems, Inc.2023-03-03
K210509Rocket Platinum Cured CathterRocket Medical Plc2021-09-09
K201404Passio Pump Drainage SystemBearpac Medical2020-11-20
K190292Passio Pump Drainage SystemBearpac Medical2019-07-25
K163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical Plc2017-08-17
K160450Pleurx Pleural Catheter SystemCare Fusion2016-10-31
K141965PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KITCare Fusion2015-07-02
K123033ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE BRocket Medical Plc2013-02-01
K121849PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEECare Fusion2012-10-18
K110409ASPIRA PLEURAL DRAINAGE SYSTEMC.R. Bard, Inc.2011-05-11
K093307ASEPT PLEURAL DRAINAGE SYSTEMPfm Medical, Inc.2009-11-06
K071095ASPIRA PLEURAL DRAINAGE SYSTEMBard Access Systems, Inc.2007-05-18
K052436PLEURX PLEURAL CATHETER KIT, MODEL 50-7000Denver Biomedical, Inc.2005-10-06
K051084DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINEDenver Biomedicals, Inc.2005-06-13
K011831MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITSDenver Biomedical, Inc.2001-06-28

Legacy Summary#

summary

FDA Review#

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