FDA.reportPublic FDA data

510(k) K212696

Device
Aspira Pleural Drainage System
Applicant
Merit Medical Systems, Inc.
510(k) number
K212696
Product code
DWM
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-03
Date received
2021-08-25
Regulation
870.5050
Classification name
Apparatus, Suction, Patient Care
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jennifer Webb
Address
1600 W. Merit Pkwy. South Jordan UT US 84095 84095

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
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
K112831PLEURX PLEURAL CATHETER SYSTEMSCare Fusion2012-02-16
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