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) |
|---|---|---|---|
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 5Fx90 GUIDING CATH HH
Product Code: GHH50900000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 6Fx90 GUIDING CATH ST
Product Code: GST60900000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 5Fx90 GUIDING CATH ST
Product Code: GST50900000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 5Fx100 GUIDING CATH ST
Product Code: GST51000000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 5Fx90 GUIDING CATH MPD
Product Code: GMD50900000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 6Fx100 GUIDING CATH MP
Product Code: GMD61000000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 5Fx90 GUIDING CATH MPC
Product Code: GMC50900000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 5Fx90 GUIDING CATH MCV
Product Code: GCB50900000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 5Fx100 GUIDING CATH MC
Product Code: GCB51000000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 6Fx100 GUIDING CATH S2
Product Code: GSM61000000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 6Fx100 GUIDING CATH MC
Product Code: GCB61000000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 5Fx100 GUIDING CATH S2
Product Code: GSM51000000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 6Fx100 GUIDING CATH ST
Product Code: GST61000000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 5Fx100 GUIDING CATH MP
Product Code:GMD51000000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 6Fx100 GUIDING CATH MPD
Product Code: GMD60900000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 5Fx100 GUIDING CATH HH
Product Code: GMC51000000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 5Fx100 GUIDING CATH HH
Product Code: GHH51000000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 6Fx90 GUIDING CATH HH
Product Code: GHH60900000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 5Fx90 GUIDING CATH S2
Product Code: GSM50900000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 6Fx90 GUIDING CATH MPC
Product Code: GMC60900000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
| Feb 11, 2013 | St Jude Medical Inc St. Jude Medical, AGA Medical corporation, AMPLATZER TorqVue FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITV Terminated |
DQY | K121611 |
| Jan 8, 2013 | Concentric Medical Inc FlowGate Balloon Guide Catheter;
Manufactured by Concentric Medical, Mountain View, CA.
FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinfor Terminated |
DQY | K122581 |
| Sep 25, 2012 | Applied Medical Resources Corp Irrigation Catheters (Models IRR-XXX-XX):
Model Numbers & Description:
IRR-023-10F,CATHETER IRRIGATION 10F 23CM;
IRR-080-4F, CATHETER, IRRIGATION 4F 80CM;
IRR-080-6F, CATHETER, IRRIGATION 6F 80CM.
I Terminated |
DQY | K902256 |
| Jul 24, 2012 | Bridgepoint Medical BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441.
St Terminated |
DQY | K080987 K101591 +1 |
| May 24, 2012 | Vascular Solutions, Inc. Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369.
Intended to be used in conjunction wit Terminated |
DQY | K112082 |
| Sep 19, 2011 | Angiodynamics Worldwide Headquarters ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801105, BALLOON DIAMETER 5MM, BALLOON LENGTH 4 CM, CATHETER LENGTH 40 CM, STERILE, MANUFACTURED IN USA AngioDynamics 603 Queensbu Terminated |
DQY | K062609 |
| Sep 19, 2011 | Angiodynamics Worldwide Headquarters ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801101, BALLOON DIAMETER 4MM, BALLOON LENGTH 2 CM, CATHETER LENGTH 40 CM, STERILE, MANUFACTURED IN USA AngioDynamics 603 Queensbu Terminated |
DQY | K062609 |
| Aug 4, 2011 | Spectranetics Corporation Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907.
Designed for directing and supporting Spectr Terminated |
DQY | K071226 |
| Aug 4, 2011 | Spectranetics Corporation Spectranetics Turbo-Booster Laser Guide Catheter, 7 Fr, REF 518-043, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907.
Designed for directing and supporting Spectr Terminated |
DQY | K071226 |
| Jul 12, 2011 | Abbott Vascular Guidant RAPIDO Cut-Away Guiding Catheter, 6F.
Part Numbers: 66676-201 and 667552-100.
For use in cardiac diagnostic and therapeutic procedures. Terminated |
DQY | K021455 K031459 +3 |
| Jun 8, 2011 | Medtronic Vascular Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes
Catalog Number: Z26AL15SH
The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are in Terminated |
DQY | K010579 K990707 |
| Feb 17, 2011 | Arrow International Inc JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04800.
Jugular puncture kit Terminated |
DQY | K820009 |
| Feb 17, 2011 | Arrow International Inc CENTRAL VENOUS CATHETERIZATION KIT/Product SKU's (Codes) AK-04650-E and AK-04660.
Central venous catheterization kit Terminated |
DQY | K820009 |
| Feb 17, 2011 | Arrow International Inc VESSEL CATHETERIZATION KIT/Product SKU's (Codes) AK-04550, AK-4550-A and ASK-04550-TG.
Vessel catheterization kit Terminated |
DQY | K820009 |
| Feb 17, 2011 | Arrow International Inc PEDIATRIC JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04150-E
Pediatric jugular puncture kit Terminated |
DQY | K820009 |
| Feb 17, 2011 | Arrow International Inc INTERNAL JUGULAR PUNCTURE KIT with Blue FlexTip(R) Catheter/Product SKU (Code) AK-04050
Internal jugular puncture kit Terminated |
DQY | K820009 |
| Feb 14, 2011 | Thomas Medical Products Inc Thomas Medical Products, Acuity Bleed back Control Valve, Acuity Rotating Hemostasis Valve, Acuity Universal Cutter, and Contamination Sleeve for use during vascular interventional procedures. Contam Terminated |
DQY | K003731 K072745 +1 |
| Jan 24, 2011 | Flowcardia Inc. Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA
Intended use: Catheter for use in surgery. Terminated |
DQY | K072776 |
| Jan 12, 2011 | Arrow International Inc Arrow-Howes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter. Catalog #: CV-15703.
Permits venous access to the central circulation. Terminated |
DQY | K862056 |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific Guider Softip TM XF Guide Catheter
Catheter is intended to facilitate the placement of interventional devices into the neurovascular system. Terminated |
DQY | None listed |
| Jan 6, 2011 | Medtronic CardioVascular Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath and placed percutaneously into a peripheral vessel. The device tracks to its intended site in the vasculatur Terminated |
DQY | K081804 |
| Jan 4, 2011 | AngioScore Inc. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 50 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2105-6020 Terminated |
DQY | K072225 K080151 +1 |
| Jan 4, 2011 | AngioScore Inc. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2092-6020. Terminated |
DQY | K072225 K080151 +1 |
| Jan 4, 2011 | AngioScore Inc. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 6.0 mm x 20 mm balloon size, Part (REF) number: 2076-6020. Terminated |
DQY | K072225 K080151 +1 |
| Jan 4, 2011 | AngioScore Inc. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 5.0 mm x 20 mm balloon size, Part (REF) number: 2076-5020. Terminated |
DQY | K072225 K080151 +1 |
| Jan 4, 2011 | AngioScore Inc. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter;
OTW 0.018" Platform, 137 cm, 4.0 mm x 20 mm balloon size. Part (REF) number: 2076-4020 Terminated |
DQY | K072225 K080151 +1 |
| Dec 23, 2010 | Ev3, Inc. ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF #'s: AB14W040040150, AB14W030040150, AB14W020040150, AB14W025080150, AB14W020080150, AB14W020120150, AB14W030 Terminated |
DQY | K082854 K090849 |
| Sep 25, 2010 | Arrow International Inc Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue Catheter Terminated |
DQY | K820648 |
| Sep 25, 2010 | Arrow International Inc Multi-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety Features) Terminated |
DQY | K820648 |
| Sep 25, 2010 | Arrow International Inc Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety Features) Terminated |
DQY | K820648 |
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