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)
Top companies in DTL
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2012 | Vascular 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 |
DTL | K092711 K101113 |
| Jul 12, 2011 | Abbott Vascular Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve
Part Number : 1003330. For use in cardiac diagnostic or therapeutic procedures. Terminated |
DTL | K991102 |
| Feb 14, 2011 | Thomas 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 |
DTL | K003731 K072745 +1 |
| Dec 7, 2010 | Edwards Lifesciences Llc Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614. Terminated |
DTL | K892377 |
| Dec 7, 2010 | Edwards Lifesciences Llc Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614 Terminated |
DTL | K892377 |
| Sep 30, 2008 | Medtronic 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 |
DTL | K052459 |
| Feb 1, 2007 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation ACS Rotating Hemostatic Valve, .115 inch, for use with a dilatation catheter - Reference Number 23245 Terminated |
DTL | K934624 |
| Feb 1, 2007 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation ACS DUOSTAT Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23244 Terminated |
DTL | K854261 K861847 |
| Feb 1, 2007 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23242 Terminated |
DTL | K854261 K861847 |
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