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

DateFirm and productCodeLinked 510(k)
Nov 2, 2016Stryker 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
DQYK010853
K980453
Nov 2, 2016Stryker 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
DQYK010853
K980453
Nov 2, 2016Stryker 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
DQYK010853
K980453
Nov 2, 2016Stryker 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
DQYK010853
K980453
Nov 2, 2016Stryker 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
DQYK010853
K980453
Nov 2, 2016Stryker 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
DQYK010853
K980453
Nov 2, 2016Stryker 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
DQYK010853
K980453
Nov 2, 2016Stryker 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
DQYK010853
K980453
Nov 2, 2016Stryker 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
DQYK010853
K980453
Nov 2, 2016Stryker 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
DQYK010853
K980453
Nov 2, 2016Stryker 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
DQYK010853
K980453
Oct 20, 2016Vascular 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
DQYK060327
Oct 20, 2016Vascular 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
DQYK052257
Aug 22, 2016Cook Inc.
White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.
Terminated
DQYK902905
Feb 24, 2016Cook 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
DQYNone listed
Feb 24, 2016Cook 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
DQYNone listed
Feb 24, 2016Cook 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
DQYNone listed
Feb 24, 2016Cook 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
DQYNone listed
Jan 5, 2016Boston 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
DQYK132914
Nov 6, 2015Medtronic Vascular, Inc.
Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 AMP020040152 AMP025040152 AMP025150152 AMP030120152 AMP040080
Terminated
DQYK042624
K050073 +2
Oct 9, 2015Concentric 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
DQYK133177
Apr 10, 2015Bard Peripheral Vascular Inc
Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.
Terminated
DQYK083657
Mar 13, 2015Bard 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
DQYK871080
Dec 12, 2014Concentric 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
DQYK110483
Nov 13, 2014Medtronic Vascular
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Terminated
DQYK021256
Oct 16, 2014Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit
Terminated
DQYK862056
Oct 14, 2014Arrow International Inc
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
Terminated
DQYK011761
K073451 +3
Apr 23, 2014Ev3, 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
DQYK082579
K103322
Apr 16, 2014Micro Therapeutics Inc, Dba Ev3 Neurovascular
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
Terminated
DQYK043580
Apr 16, 2014Micro Therapeutics Inc, Dba Ev3 Neurovascular
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
Terminated
DQYNone listed
Mar 10, 2014Boston Scientific Corporation
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Terminated
DQYK033441
Dec 13, 2013Stryker 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
DQYK042568
Dec 13, 2013Stryker 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
DQYK042568
Dec 13, 2013Stryker 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
DQYK042568
Dec 13, 2013Stryker 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
DQYK013789
Dec 13, 2013Stryker 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
DQYK042568
Dec 13, 2013Stryker 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
DQYK042568
Dec 13, 2013Stryker 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
DQYK042568
Dec 13, 2013Stryker 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
DQYK042568
Oct 1, 2013Cordis 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
DQYK131225
Aug 14, 2013Arrow 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
DQYK862056
Jun 21, 2013Medtronic 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
DQYK021256
K103386
Jun 12, 2013Bard 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
DQYK073472
Jun 10, 2013Bard 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
DQYK090547
Jun 10, 2013Bard 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
DQYK090547
Feb 20, 2013Vascular 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
DQYK101659
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004

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