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)
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 20, 2013Codman & 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
DQYK052004
Feb 11, 2013St 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
DQYK121611
Jan 8, 2013Concentric Medical Inc
FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinfor
Terminated
DQYK122581
Sep 25, 2012Applied 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
DQYK902256
Jul 24, 2012Bridgepoint 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
DQYK080987
K101591 +1
May 24, 2012Vascular 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
DQYK112082
Sep 19, 2011Angiodynamics 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
DQYK062609
Sep 19, 2011Angiodynamics 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
DQYK062609
Aug 4, 2011Spectranetics 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
DQYK071226
Aug 4, 2011Spectranetics 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
DQYK071226
Jul 12, 2011Abbott Vascular
Guidant RAPIDO Cut-Away Guiding Catheter, 6F. Part Numbers: 66676-201 and 667552-100. For use in cardiac diagnostic and therapeutic procedures.
Terminated
DQYK021455
K031459 +3
Jun 8, 2011Medtronic 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
DQYK010579
K990707
Feb 17, 2011Arrow International Inc
JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04800. Jugular puncture kit
Terminated
DQYK820009
Feb 17, 2011Arrow International Inc
CENTRAL VENOUS CATHETERIZATION KIT/Product SKU's (Codes) AK-04650-E and AK-04660. Central venous catheterization kit
Terminated
DQYK820009
Feb 17, 2011Arrow International Inc
VESSEL CATHETERIZATION KIT/Product SKU's (Codes) AK-04550, AK-4550-A and ASK-04550-TG. Vessel catheterization kit
Terminated
DQYK820009
Feb 17, 2011Arrow International Inc
PEDIATRIC JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04150-E Pediatric jugular puncture kit
Terminated
DQYK820009
Feb 17, 2011Arrow International Inc
INTERNAL JUGULAR PUNCTURE KIT with Blue FlexTip(R) Catheter/Product SKU (Code) AK-04050 Internal jugular puncture kit
Terminated
DQYK820009
Feb 14, 2011Thomas 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
DQYK003731
K072745 +1
Jan 24, 2011Flowcardia Inc.
Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA Intended use: Catheter for use in surgery.
Terminated
DQYK072776
Jan 12, 2011Arrow 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
DQYK862056
Jan 7, 2011Boston 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
DQYNone listed
Jan 6, 2011Medtronic 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
DQYK081804
Jan 4, 2011AngioScore 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
DQYK072225
K080151 +1
Jan 4, 2011AngioScore 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
DQYK072225
K080151 +1
Jan 4, 2011AngioScore 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
DQYK072225
K080151 +1
Jan 4, 2011AngioScore 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
DQYK072225
K080151 +1
Jan 4, 2011AngioScore 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
DQYK072225
K080151 +1
Dec 23, 2010Ev3, Inc.
ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF #'s: AB14W040040150, AB14W030040150, AB14W020040150, AB14W025080150, AB14W020080150, AB14W020120150, AB14W030
Terminated
DQYK082854
K090849
Sep 25, 2010Arrow International Inc
Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue Catheter
Terminated
DQYK820648
Sep 25, 2010Arrow International Inc
Multi-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety Features)
Terminated
DQYK820648
Sep 25, 2010Arrow International Inc
Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety Features)
Terminated
DQYK820648

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