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)
Top companies in DQY
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Vascular | 31 | 198 |
| Medtronic | 15 | 148 |
| Boston Scientific | 30 | 59 |
| ARROW INTERNATIONAL, LLC | 0 | 41 |
| Stryker Neurovascular | 6 | 30 |
| Cook Incorporated | 22 | 13 |
| Vascular Solutions, Inc. | 27 | 6 |
| Codman & Shurtleff, Inc. | 8 | 24 |
| Bard Peripheral Vascular, Inc. | 5 | 23 |
| Cordis Corp. | 22 | 4 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2010 | Bard Peripheral Vascular Inc BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135720 Terminated |
DQY | K072283 |
| Aug 2, 2010 | Bard Peripheral Vascular Inc BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135717 Terminated |
DQY | K072283 |
| Aug 2, 2010 | Bard Peripheral Vascular Inc BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135715 Terminated |
DQY | K072283 |
| Aug 2, 2010 | Bard Peripheral Vascular Inc BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135712 Terminated |
DQY | K072283 |
| Aug 2, 2010 | Bard Peripheral Vascular Inc BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135620 Terminated |
DQY | K072283 |
| Aug 2, 2010 | Bard Peripheral Vascular Inc BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135615 Terminated |
DQY | K072283 |
| Aug 2, 2010 | Bard Peripheral Vascular Inc BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135612 Terminated |
DQY | K072283 |
| Aug 2, 2010 | Bard Peripheral Vascular Inc BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135520 Terminated |
DQY | K072283 |
| Aug 2, 2010 | Bard Peripheral Vascular Inc BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135517 Terminated |
DQY | K072283 |
| Aug 2, 2010 | Bard Peripheral Vascular Inc BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135515 Terminated |
DQY | K072283 |
| Aug 2, 2010 | Bard Peripheral Vascular Inc BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135512 Terminated |
DQY | K072283 |
| Aug 2, 2010 | Bard Peripheral Vascular Inc BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135420 Terminated |
DQY | K072283 |
| Aug 2, 2010 | Bard Peripheral Vascular Inc BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135417 Terminated |
DQY | K072283 |
| Aug 2, 2010 | Bard Peripheral Vascular Inc BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135415 Terminated |
DQY | K072283 |
| Aug 2, 2010 | Bard Peripheral Vascular Inc BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135412 Terminated |
DQY | K072283 |
| Mar 11, 2010 | AGA Medical Corporation AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the Terminated |
DQY | K072313 |
| Dec 23, 2009 | Ev3, Inc. TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO.
US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135,
SC-014-150, SC-018-150, Terminated |
DQY | K092299 |
| Nov 20, 2009 | Boston Scientific Corporation Guider XF Softip Guide Catheter, manufactured by Boston Scientific Corporation, Maple Grove, MN, distributed by Boston Scientific Corporation, Fremont, CA.
The device is intended to facilitate placem Terminated |
DQY | K980453 |
| Nov 13, 2009 | Boston Scientific Corporation Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Terminated |
DQY | K021721 |
| Nov 13, 2009 | Boston Scientific Corporation Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Terminated |
DQY | K021721 |
| Nov 13, 2009 | Boston Scientific Corporation Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Terminated |
DQY | K021721 |
| Nov 13, 2009 | Boston Scientific Corporation Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Terminated |
DQY | K021721 |
| Oct 5, 2009 | Penumbra Inc. Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA.
Indicated for t Terminated |
DQY | K082290 |
| Sep 24, 2009 | Penumbra Inc. Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA
Percutaneous Catheter, indicated for the introduction of interventional devices into the periphera Terminated |
DQY | K070970 |
| Sep 8, 2009 | Penumbra Inc. Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA.
Intended for the introduction of interventional devices into the pe Terminated |
DQY | K083125 |
| Aug 21, 2009 | Vascular Solutions, Inc. Twin-Pass Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic, Manufactured by Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369.
The TWIN-PASS Terminated |
DQY | K060327 |
| Jul 7, 2009 | Arrow International Inc Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502. Terminated |
DQY | K862056 |
| Jun 24, 2009 | Arrow International Inc Arrow Multi-Lumen CVC w/ BlueFlex Tip (Central Venous Catheter) Terminated |
DQY | K862056 |
| Jun 24, 2009 | Arrow International Inc Arrow Single Lumen CVCs (Central Venous Catheters) Terminated |
DQY | K820009 |
| Jun 18, 2009 | Boston Scientific Corporation Boston Scientific Wiseguide Guide Catheter, Sterilized.
Wiseguide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical inst Terminated |
DQY | K970823 K974684 +1 |
| Oct 7, 2008 | Boston Scientific Corporation Excelsior SL-10 Microcatheter, placed in sterile pouch. Manufactured by Boston Scientific Corporation, Fremont, CA.
The ExcelsiorTM SL-10 Microcatheter is intended to assist in the delivery of diagn Terminated |
DQY | K013789 |
| Sep 30, 2008 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Attain ACCESS 6218A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland, Parkmore Business Park West, Galway, Ireland. Medtronic, Inc., 710 Medtronic Parkway, Mi Terminated |
DQY | K021589 |
| Sep 30, 2008 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Attain LDS 6216A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland, Parkmore Business Park West, Galway, Ireland. Medtronic, Inc., 710 Medtronic Parkway, Minnea Terminated |
DQY | K021587 |
| Aug 13, 2008 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation 6F Viking Guiding Catheter, Percutaneous catheter Shape BP-L, Part Number: 1001970-06, Abbott Vascular, Santa Clara, CA 95054.
Intended to provide a pathway through which therapeutic and diagnostic d Terminated |
DQY | K972484 |
| Aug 13, 2008 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation 6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2, Part Number: 1001934-06, Abbott Vascular, Santa Clara, CA 95054.
Designed to provide a pathway trough which therapeutic and diagnosti Terminated |
DQY | K972484 |
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic Bio-Medicus Percutaneous Cannula & Introducer Set, Catalog Number: CB96535-015 Terminated |
DQY | K884129 |
| May 7, 2008 | Boston Scientific Corporation Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-866, UPN M001198660, Sterile EO, Availmed S.A. de C.V. (M Terminated |
DQY | K010874 K020028 |
| May 7, 2008 | Boston Scientific Corporation Boston Scientific Mach 1 peripheral Guide Catheter 7F, MP Multipurpose, .081 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-723, UPN M001197230, Sterile EO, Availmed S.A. de C.V. (Mexico), Terminated |
DQY | K010874 K020028 |
| May 7, 2008 | Boston Scientific Corporation Boston Scientific Mach 1 peripheral Guide Catheter 6F, RDC Renal double Curve, .070 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-666, UPN M001196660, Sterile EO, Availmed S.A. de C.V. (M Terminated |
DQY | K010874 K020028 |
| May 7, 2008 | Boston Scientific Corporation Boston Scientific Mach 1 peripheral Guide Catheter 6F, MP Multipurpose 90cm, .070 in (internal dia), Shaft lenght 90cm, Catalog Number: 19-626, UPN M001196260, Sterile EO, Availmed S.A. de C.V. (Mex Terminated |
DQY | K010874 K020028 |
| May 7, 2008 | Boston Scientific Corporation Boston Scientific Mach 1 peripheral Guide Catheter 6F, HS Hockey Stick, .070 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-600, UPN M001196000, Sterile EO, Availmed S.A. de C.V. (Mexico), Terminated |
DQY | K010874 K020028 |
| May 7, 2008 | Boston Scientific Corporation Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in (internal dia), shaft lenght, 90 cm, Catalon Number: 34356-446, UPN H749343564460, Sterile EO, Availmed S.A. de C.V. (Mexi Terminated |
DQY | K010874 K020028 |
| Feb 5, 2008 | Spectranetics Corporation Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907. Terminated |
DQY | None listed |
| Nov 24, 2007 | Boston Scientific Target Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number: 10142, Single-use Disposable Guide Catheters Terminated |
DQY | K980453 |
| Nov 24, 2007 | Boston Scientific Target Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 90cm usable length, Material Number (UPN) H965100420, Catalog Number : 10042, Made in USA: 5905 Nathan Lane, Plymout Terminated |
DQY | K980453 |
| Oct 27, 2007 | Boston Scientific Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H74934358780, Sterile EO, Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial La Mesa, Fracc. Terminated |
DQY | K020028 |
| Oct 27, 2007 | Boston Scientific Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358-268, UPN H749343582680, Sterile EO Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial Terminated |
DQY | None listed |
| Mar 29, 2007 | Cook, Inc. Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no Terminated |
DQY | K052036 |
| Feb 7, 2007 | Boston Scientific Boston Scientific Mach 1 Peripheral Guide Catheter, 6F, 55cm, LIMA Tip Shape, UPN # M001196620, Catalog # 19-662. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja Cal Terminated |
DQY | K010874 |
| Feb 7, 2007 | Boston Scientific Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081'', Voda Left Curve, UPN # H74934357730, Catalog # 34357-73. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tij Terminated |
DQY | K020028 |
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