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510(k) K894721

Device
Traumafuse Perfusion Pressure Relief Valve
Applicant
THE TRAUMAFUSE CO.
510(k) number
K894721
Product code
DWE
Decision
Substantially Equivalent (SESE)
Decision date
1989-10-20
Date received
1989-07-25
Regulation
870.4390
Classification name
Tubing, Pump, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT L DOUP
Address
2340 Riverbend Rd. Allentown PA US 18103 18103

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DWE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233702SMARxT Tubing and ConnectorsLivaNova USA, Inc.2024-08-08
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
K841959CARDIO METRIC CUSTOM PERFUSION TUBINGSterile Design, Inc.1984-10-19