FDA.reportPublic FDA data

510(k) K233702

Device
SMARxT Tubing and Connectors
Applicant
LivaNova USA, Inc.
510(k) number
K233702
Product code
DWE
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-08
Date received
2023-11-17
Regulation
870.4390
Classification name
Tubing, Pump, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tatjana Kuntschik
Address
14401 W. 65th Way Arvada CO US 80004 80004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DWE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150542Terumo Pump TubingTerumo Cardiovascular Systems Corporation2015-05-01
K142607AngioVac CircuitAngiodynamics2014-12-11
K092486VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUITVortex Medical, Inc.2009-08-28
K080592HLM TUBING SET WITH BIOLINE COATINGMaquet Cardiopulmonary, AG2008-09-11
K053025JOSTRA HLM TUBING SETMaquet Cardiopulmonary, AG2005-11-10
K022857PUMP TUBING WITH X-COATINGTerumo Cardiovascular Systems Corporation2002-09-19
K013578PUMP TUBINGTerumo Cardiovascular Systems Corp.2002-01-22
K993189CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBINGTerumo Corp.2000-03-01
K993062CHEST DRAINAGE TUBINGOlson Medical Sales, Inc.1999-12-10
K981613COBE SMARXT TUBING AND CONNECTORSCobe Cardiovascular, Inc.1998-10-26
K923231CARDIO-PAK BASIC PUMP PACKCardio-Med-Associates, Inc.1993-07-09
K905686SARNS TEMPERATURE PROBE AND CONNECTOR3M Health Care, Sarns1991-02-25
K902845GENTLE HEADEREnhanced Perfusion Systems, Inc.1990-12-03
K894721TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVEThe Traumafuse Co.1989-10-20
K841959CARDIO METRIC CUSTOM PERFUSION TUBINGSterile Design, Inc.1984-10-19