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)
Feb 7, 2007Boston Scientific
Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091'', Amplatz Left Curve, UPN # H74934358190, Catalog # 34358-19. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa,
Terminated		 DQYK020028
Feb 7, 2007Boston Scientific
Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091'', Amplatz Right Curve, UPN # H74934358180, Catalog # 34358-18. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa,
Terminated		 DQYK020028
Feb 7, 2007Boston Scientific
Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081'', Multipurpose Curve, UPN # H74934357380, Catalog # 34357-38. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa,
Terminated		 DQYK020028
Feb 7, 2007Boston Scientific
Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Voda Left Curve, UPN # H74934356710, Catalog # 34356-71. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tij
Terminated		 DQYK010874
Feb 7, 2007Boston Scientific
Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Internal Mammary Curve, UPN # H74934356260, Catalog # 34356-26. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Me
Terminated		 DQYK010874
Nov 2, 2006Enpath Medical, Inc.
Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Labeled
Terminated		 DQYK043489
Jun 24, 2006St Jude Medical CRMD
CPS Implant Kit, Model 410190
Terminated		 DQYK053217
Jun 24, 2006St Jude Medical CRMD
CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148
Terminated		 DQYK053217
Jun 24, 2006St Jude Medical CRMD
CPS Direct SL, Models 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120, 410121, 410122, 410123, 410124, 410125, & 410126
Terminated		 DQYK053217
Jun 24, 2006St Jude Medical CRMD
CPS Valve Bypass Tool (VBT), Model 410192
Terminated		 DQYK053217
Jun 24, 2006St Jude Medical CRMD
CPS Slitter, Model 410191
Terminated		 DQYK053217
Jun 10, 2006Boston Scientific
Boston Scientific Wiseguide Guide Catheter 7F, .076 '', Femoral Approach, Manufactured for Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311. Nonpyrogenic.
Terminated		 DQYK974684
Jun 1, 2006Medtronic, Inc.
6F ZUMA SR5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Cod
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
6F ZUMA SR4.0 CATHETER ZM6SR40 ZM 6F 100CM SR4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or periph
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
6F ZUMA SR3.5 CATHETER ZM6SR35 ZM 6F 100CM SR3.5 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or periph
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
6F ZUMA SR3.0 CATHETER ZM6SR30 ZM 6F 100CM SR3.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or periph
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
6F ZUMA SL5.0 CATHETER ZM6SL50 ZM 6F 100CM SL5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or per
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
6F ZUMA MAC 4.0 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. Pro
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
6F ZUMA MAC 3.5 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. Pro
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
6F ZUMA JR5.0 110CM CATHETER ZM61JR50A ZM 6F 110CM JR5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary o
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
ZM6JR40A 6F ZUMA JR4.0 110CM CATHETER ZM6JR40A ZM 6F 110CM JR4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the co
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
CATH, GUIDE 6F JL6.0 110CM ZUM CATHETER ZM6JL60A ZM 6F 110CM JL60 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the c
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
6F ZUMA JL40 110CM CATHETER ZM6JL40A ZM 6F 110CM JL4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
6F ZUMA JL40 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. Product
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
6F ZUMA EBU4.0 W/110CM LENGTH GUID CATH 6F ZUMA EBU4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coron
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
6F ZUMA EBU3.5 W/110CM LENGTH CATHETER ZM6EBU35A ZM 6F 110CM EB35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the c
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
6F ZUMA DC4.0 W/110CM LENGTH GUID CATH 6F ZUMA DC 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronar
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
6F ZUMA DC3.5 W/110CM LENGTH GUID CATH 6F ZUMA DC 3.5 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the corona
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
6F ZUMA AR2.0 CATHETER ZM6AR20A ZM 6F 110CM AR2.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or perip
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
CATHETER ZM6AL20A ZM 6F 110CM AL2.0 ZUMA 6F AL2.0 110 CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary o
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
6F ZUMA AL1.0 W/110CM LENGTH CATHETER ZM6AL10A ZM 6F 110CM AL1.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the co
Terminated		 DQYK981198
Jun 1, 2006Medtronic, Inc.
5F ZUMA SR5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Cod
Terminated		 DQYK990707
Jun 1, 2006Medtronic, Inc.
5F ZUMA SR4.0 CATHETER ZM5SR40 Z2 5F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or periphe
Terminated		 DQYK990707
Jun 1, 2006Medtronic, Inc.
ZM5SR35 5F ZUMA SR3.5 CATHETER ZM5SR35 Z2 5F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or
Terminated		 DQYK990707
Jun 1, 2006Medtronic, Inc.
5F ZUMA SR3.0 CATHETER ZM5SR30 Z2 5F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or periphe
Terminated		 DQYK990707
Jun 1, 2006Medtronic, Inc.
8F ZUMA 2 SR 5.0 SH 100CM 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		 DQYK982883
Jun 1, 2006Medtronic, Inc.
8F ZUMA 2 SR 5.0 100CM CATHETER Z28SR50 Z2 8F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary o
Terminated		 DQYK982883
Jun 1, 2006Medtronic, Inc.
8F ZUMA 2 SR 4.0 SH 100CM 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		 DQYK982883
Jun 1, 2006Medtronic, Inc.
8F ZUMA 2 SR 4.0 100CM CATHETER Z28SR40 Z2 8F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary o
Terminated		 DQYK982883
Jun 1, 2006Medtronic, Inc.
8F ZUMA 2 SR 3.5 SH 100CM 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		 DQYK982883
Jun 1, 2006Medtronic, Inc.
8F ZUMA 2 SR 3.5 100CM CATHETER Z28SR35 Z2 8F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary o
Terminated		 DQYK982883
Jun 1, 2006Medtronic, Inc.
8F ZUMA 2 SR 3.0 100CM CATHETER Z28SR30 Z2 8F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary o
Terminated		 DQYK982883
Jun 1, 2006Medtronic, Inc.
CATH. GUIDE 8F MB1 W/SH 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular syste
Terminated		 DQYK982883
Jun 1, 2006Medtronic, Inc.
CATH. GUIDE 8F FR4.0 W/SH 110C Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular syst
Terminated		 DQYK982883
Jun 1, 2006Medtronic, Inc.
CATH. GUIDE 8F EBU5.0 W/SH 110 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular syst
Terminated		 DQYK982883
Jun 1, 2006Medtronic, Inc.
CATH. GUIDE 8F EBU4.0 W/SH 110 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular syst
Terminated		 DQYK023402
Jun 1, 2006Medtronic, Inc.
CATH. GUIDE 8F EBU3.5 W/SH 110 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular syst
Terminated		 DQYK023402
Jun 1, 2006Medtronic, Inc.
CATH. GUIDE 8F AR1.0 W/SH 110C Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular syst
Terminated		 DQYK023402
Jun 1, 2006Medtronic, Inc.
7F ZUMA 2 SR5.0 100CM CATHETER Z27SR50 Z2 7F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or
Terminated		 DQYK010579
Jun 1, 2006Medtronic, Inc.
7F ZUMA 2 SR4.0 SH 100CM CATHETER Z27SR40SH Z2 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronar
Terminated		 DQYK010579

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