ClearanceBrief
Panels › Cardiovascular › Product code DQY · Class 2

Catheter, Percutaneous

Regulation 870.1250

13510(k)s in 12 months (896 all time)
2recalls in 12 months (620 all time)
583recalls that name a 510(k)
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Top companies in DQY

Company510(k)sRecalls
Medtronic Vascular31198
Medtronic15148
Boston Scientific3059
ARROW INTERNATIONAL, LLC041
Stryker Neurovascular630
Cook Incorporated2213
Vascular Solutions, Inc.276
Codman & Shurtleff, Inc.824
Bard Peripheral Vascular, Inc.523
Cordis Corp.224
DateFirm and productCodeLinked 510(k)
Jun 1, 2006Medtronic, Inc.
CATH. GUIDE 6F 3DRC W/SH LAUNC CATHETER LA63DRCSH LA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the
Terminated		 DQYK021256
Jun 1, 2006Medtronic, Inc.
CATH. GUIDE 6F 3DRC LAUNCHER CATHETER LA63DRC LA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coron
Terminated		 DQYK021256
Jun 1, 2006Medtronic, Inc.
CATH.GUIDE 5F SR 5.0 110CM CATHETER LA5SR50A LA 5F 110CM SR5 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the corona
Terminated		 DQYK030779
Jun 1, 2006Medtronic, Inc.
CATH GUIDE 5F SR4.0 LAUNCHER CATHETER LA5SR40 LA 5F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coro
Terminated		 DQYK030779
Jun 1, 2006Medtronic, Inc.
CATH GUIDE 5F SR3.5 LAUNCHER CATHETER LA5SR35 LA 5F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coro
Terminated		 DQYK030779
Jun 1, 2006Medtronic, Inc.
CATH GUIDE 5F SR3.0 LAUNCHER CATHETER LA5SR30 LA 5F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coro
Terminated		 DQYK030779
Jun 1, 2006Medtronic, Inc.
CATH.GUIDE 5F JR 4.0 110CM CATHETER LA5JR40A LA 5F 110CM JR4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coro
Terminated		 DQYK030779
Jun 1, 2006Medtronic, Inc.
CATH.GUIDE 5F JL 4.0 110CM CATHETER LA5JL40A LA 5F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coro
Terminated		 DQYK030779
Jun 1, 2006Medtronic, Inc.
CATHETER LA5IMAA 5F 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system.
Terminated		 DQYK030779
Jan 24, 2006Boston Scientific Scimed
Mach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacture: Boston Scientific Scimed, Inc., One Sc
Terminated		 DQYK010874
Jan 24, 2006Boston Scientific Scimed
Mach 1 6F Kimny Guide Catheter. Catalog No. 34356-583. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacturer: Boston Scientific Scimed, Inc., One Sci
Terminated		 DQYK010874
Mar 10, 2005Cordis Corporation
Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use only. Catalog number 4038553S
Terminated		 DQYK001136
Jan 28, 2005Boston Scientific Scimed
RunWay 6F Cardiovascular Guide Catheter.
Terminated		 DQYK033441
Jan 26, 2005Cordis Corporation
VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.
Terminated		 DQYK021593
Nov 11, 2004Merit Medical Systems, Inc
Safety Paracentesis Procedure Tray
Terminated		 DQYNone listed
Jul 20, 2004Lumend Inc
LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas.
Terminated		 DQYK032298
Jul 20, 2004Concentric Medical Inc
Concentric brand Concentric Retriever X6 Percutaneous Catheter Model REF 90037
Terminated		 DQYK030476
Jul 20, 2004Concentric Medical Inc
Concentric brand Concentric Retriever X5 Percutaneous Catheter Model REF 90035
Terminated		 DQYK003410
K030476
Oct 15, 2003Bard Peripheral Vascular
Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Terminated		 DQYNone listed
Mar 6, 2003Medtronic,Inc/Rice Creek Facil
Atakr II RF Power Generator, Models 4802 and 4803
Terminated		 DQYNone listed

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