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) |
|---|---|---|---|
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/ST XF/6FR/100 cm, Model number:M003101500 .
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 .
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional de Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/40XF/8FR/90CM, Model number: H965100440 .
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices i Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional dev Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER MPXF 5F 100CM, Model number: M003101630.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices in Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/40DEG XF/6FR/90CM, Model number: H965100420.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional device Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/ST XF/8FR/90CM, Model number: H965100520.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices i Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/MP XF/6FR/90CM, Model number: H965100460.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices i Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/MP XF/7FR/90CM, Model number: H965100470.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices i Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/MP XF/8FR/100 cm, Model number: M003101480.
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devices Terminated |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker Neurovascular Guider Softip XF;
GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 .
Cardiology:
Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the
placement of interventional devic Terminated |
DQY | K010853 K980453 |
| Oct 20, 2016 | Vascular Solutions, Inc. Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide.
The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or Terminated |
DQY | K060327 |
| Oct 20, 2016 | Vascular Solutions, Inc. Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide.
The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the c Terminated |
DQY | K052257 |
| Aug 22, 2016 | Cook Inc. White Lumax Guiding Coaxial Catheter
Catheter, Percutaneous
Intended for the delivery of angioplasty balloons and other types of interventional devices. Terminated |
DQY | K902905 |
| Feb 24, 2016 | Cook Inc. Radial Artery Pressure Monitoring Catheter Sets and Trays
The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating Terminated |
DQY | None listed |
| Feb 24, 2016 | Cook Inc. Femoral Artery Pressure Monitoring Catheter Sets and Trays
The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating Terminated |
DQY | None listed |
| Feb 24, 2016 | Cook Inc. Single Lumen Pressure Monitoring Sets and Trays
The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are design Terminated |
DQY | None listed |
| Feb 24, 2016 | Cook Inc. Single Lumen Central Venous Catheter Sets and Trays
The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are de Terminated |
DQY | None listed |
| Jan 5, 2016 | Boston Scientific Corporation Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119.
The ACUITY Pro Lead Deli Terminated |
DQY | K132914 |
| Nov 6, 2015 | Medtronic Vascular, Inc. Amphirion Deep OTW PTA Balloon Catheter:
Model numbers:
US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 AMP020040152 AMP025040152 AMP025150152 AMP030120152 AMP040080 Terminated |
DQY | K042624 K050073 +2 |
| Oct 9, 2015 | Concentric Medical Inc Distal Access Catheters - 044 - 115 cm:
Finished Good Number 90960-001 / REF 90960.
Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlus Terminated |
DQY | K133177 |
| Apr 10, 2015 | Bard Peripheral Vascular Inc Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124. Terminated |
DQY | K083657 |
| Mar 13, 2015 | Bard Access Systems BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen)
The syringe is used to pre-flush the catheter prior to placement and Terminated |
DQY | K871080 |
| Dec 12, 2014 | Concentric Medical Inc Distal Access Catheter:
Model Numbers: 90121, 90130, 90131, 90160.
The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion cathete Terminated |
DQY | K110483 |
| Nov 13, 2014 | Medtronic Vascular Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K Terminated |
DQY | K021256 |
| Oct 16, 2014 | Arrow International Inc Multi-Lumen Central Venous Catheterization
Kit Terminated |
DQY | K862056 |
| Oct 14, 2014 | Arrow International Inc Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe. Terminated |
DQY | K011761 K073451 +3 |
| Apr 23, 2014 | Ev3, Inc. ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Periphera Terminated |
DQY | K082579 K103322 |
| Apr 16, 2014 | Micro Therapeutics Inc, Dba Ev3 Neurovascular Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal. Terminated |
DQY | K043580 |
| Apr 16, 2014 | Micro Therapeutics Inc, Dba Ev3 Neurovascular Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery. Terminated |
DQY | None listed |
| Mar 10, 2014 | Boston Scientific Corporation Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664. Terminated |
DQY | K033441 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM, Catalog Number: M0031681920; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Ex Terminated |
DQY | K042568 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand EXCELSIOR SL-10 PRE-SHAPED 90 150CM, Catalog Number: M0031681910; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
E Terminated |
DQY | K042568 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM, Catalog Number: M0031681900, Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
E Terminated |
DQY | K042568 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Excelsio Terminated |
DQY | K013789 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM; Catalog Number: M0031441920; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Ex Terminated |
DQY | K042568 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM; Catalog Number: M0031441940; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Ex Terminated |
DQY | K042568 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM; Catalog Number: M0031441930; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Ex Terminated |
DQY | K042568 |
| Dec 13, 2013 | Stryker Neurovascular Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA
Ex Terminated |
DQY | K042568 |
| Oct 1, 2013 | Cordis Corporation Cordis ADROIT 6F Guiding Catheter
Product Usage:
For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system. Terminated |
DQY | K131225 |
| Aug 14, 2013 | Arrow International Inc Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients. Terminated |
DQY | K862056 |
| Jun 21, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F
Product Usage: The Medtronic Guiding Catheter is designed to provide a pathw Terminated |
DQY | K021256 K103386 |
| Jun 12, 2013 | Bard Peripheral Vascular Inc BARD PERIPHERAL VASCULAR VACCESS PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm.
Product Usage: Vaccess PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angi Terminated |
DQY | K073472 |
| Jun 10, 2013 | Bard Peripheral Vascular Inc USHER Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745 N Terminated |
DQY | K090547 |
| Jun 10, 2013 | Bard Peripheral Vascular Inc MICROSHEATH - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc Terminated |
DQY | K090547 |
| Feb 20, 2013 | Vascular Solutions, Inc. Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341.
Product Usage:
The SuperCross catheter Terminated |
DQY | K101659 |
| Feb 20, 2013 | Codman & Shurtleff, Inc. NEUROPATH 6Fx100 GUIDING CATH MP
Product Code: GMC61000000
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 HH
Product Code: GHH61000000
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 S2
Product Code: GSM60900000
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 MCV
Product Code: GCB60900000
Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Terminated |
DQY | K052004 |
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