ClearanceBrief
Panels › Cardiovascular › Product code DTL · Class 2

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Regulation 870.4290

0510(k)s in 12 months (137 all time)
5recalls in 12 months (59 all time)
46recalls that name a 510(k)
Get daily alerts for DTLSample briefCSV

Top companies in DTL

DateFirm and productCodeLinked 510(k)
Sep 17, 2012Vascular Solutions, Inc.
Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated
Terminated
DTLK092711
K101113
Jul 12, 2011Abbott Vascular
Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For use in cardiac diagnostic or therapeutic procedures.
Terminated
DTLK991102
Feb 14, 2011Thomas Medical Products Inc
Thomas Medical Products, Y-Glide (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass) for use during vascular interventional procedures. Part No. FTB-021-00, Catalog No. FTB-021-00.
Terminated
DTLK003731
K072745 +1
Dec 7, 2010Edwards Lifesciences Llc
Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614.
Terminated
DTLK892377
Dec 7, 2010Edwards Lifesciences Llc
Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614
Terminated
DTLK892377
Sep 30, 2008Medtronic Inc. Cardiac Rhythm Managment
Medtronic Adjustable Valve, 6248VAL, Sterilized using irradiation. Medtronic, Inc. Minneapolis, MN 55432, USA. The Medtronic model 6248VAL adjustable valve is an accessory designed for use with Med
Terminated
DTLK052459
Feb 1, 2007Abbott Vascular-Cardiac Therapies dba Guidant Corporation
ACS Rotating Hemostatic Valve, .115 inch, for use with a dilatation catheter - Reference Number 23245
Terminated
DTLK934624
Feb 1, 2007Abbott Vascular-Cardiac Therapies dba Guidant Corporation
ACS DUOSTAT Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23244
Terminated
DTLK854261
K861847
Feb 1, 2007Abbott Vascular-Cardiac Therapies dba Guidant Corporation
ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23242
Terminated
DTLK854261
K861847

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.