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)
Oct 1, 2019Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 90CM.070", REF SA6AL10D. for cardiovascular use
Terminated
DQYK042489
K132673
Oct 1, 2019Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular use
Terminated
DQYK042489
K132673
Oct 1, 2019Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use
Terminated
DQYK042489
K132673
Oct 1, 2019Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular use
Terminated
DQYK042489
K132673
Oct 1, 2019Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use
Terminated
DQYK042489
K132673
Jun 2, 2019Stryker Neurovascular
Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-11196-9
Terminated
DQYK172468
Feb 7, 2019Cordis Corporation
Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or per
Terminated
DQYK021593
K143412 +3
Jan 10, 2019Arrow International Inc
Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396
Terminated
DQYK862056
Jan 10, 2019Arrow International Inc
Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
Terminated
DQYK862056
Nov 14, 2018Arrow International Inc
Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days)
Terminated
DQYK862056
Nov 13, 2018Stryker Neurovascular
Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771
Terminated
DQYK010954
K112404
Jul 28, 2018Stryker Neurovascular
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Terminated
DQYK153729
May 11, 2018Arrow International Inc
Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by wa
Terminated
DQYK862056
May 11, 2018Bard Peripheral Vascular Inc
BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature.
Terminated
DQYK103367
May 11, 2018Bard Peripheral Vascular Inc
BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature.
Terminated
DQYK103367
May 2, 2018Stryker Neurovascular
AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system
Terminated
DQYK152876
Apr 16, 2018Cook Inc.
Advance 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance 35LP Low Pro
Terminated
DQYK091527
Apr 11, 2018Arrow International Inc
Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900
Terminated
DQYK843263
Apr 11, 2018Arrow International Inc
8Fr. Catheter Clamp with Fastener; Product Code: CC-00008
Terminated
DQYK820648
Apr 11, 2018Arrow International Inc
7Fr. Catheter Clamp with Fastener; Product Code: CC-00007
Terminated
DQYK820648
Apr 11, 2018Arrow International Inc
5Fr. Catheter Clamp with Fastener; Product Code: CC-00005
Terminated
DQYK820648
Apr 11, 2018Arrow International Inc
4Fr. Catheter Clamp with Fastener; Product Code: CC-00004
Terminated
DQYK820648
Apr 11, 2018Arrow International Inc
ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
Terminated
DQYK862056
Apr 11, 2018Arrow International Inc
Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
Terminated
DQYK862056
Apr 11, 2018Arrow International Inc
Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ
Terminated
DQYK820009
Apr 11, 2018Arrow International Inc
Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF
Terminated
DQYK021120
Apr 11, 2018Arrow International Inc
Maximal Barrier Drape; Product Code: ASK-04000-HMC
Terminated
DQYK862056
Apr 11, 2018Arrow International Inc
Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418
Terminated
DQYK810962
Mar 29, 2018Medtronic Inc
6F Taiga Guiding Catheter
Terminated
DQYK083422
Mar 7, 2018SPS Sterilization, Inc
Vascular Solutions Venture Rx Catheter, 6F, resterilized.
Terminated
DQYK042910
Feb 20, 2018Arrow International Inc
Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
Terminated
DQYK862056
Feb 20, 2018Arrow International Inc
Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
Terminated
DQYK862056
Feb 20, 2018Arrow International Inc
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dates Feb 2018 - Nov 20
Terminated
DQYK862056
Feb 20, 2018Arrow International Inc
Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
Terminated
DQYK862056
Feb 20, 2018Arrow International Inc
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018
Terminated
DQYK862056
Dec 22, 2017Arrow International Inc
(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-
Terminated
DQYK862056
Dec 22, 2017Arrow International Inc
(1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterizatio
Terminated
DQYK820009
Dec 11, 2017Boston Scientific Corporation
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed wit
Terminated
DQYK010853
K980453
Oct 13, 2017Cook Inc.
Femoral Artery Pressure Monitoring Set
Terminated
DQYNone listed
Oct 13, 2017Cook Inc.
Left Atrial Catheter Set
Terminated
DQYNone listed
Oct 13, 2017Cook Inc.
Central Venous Catheter Tray
Terminated
DQYNone listed
May 22, 2017Vascular Solutions, Inc.
Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, stee
Terminated
DQYK040922
K042910 +1
May 9, 2017Arrow International Inc
Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.
Terminated
DQYK862056
May 9, 2017Arrow International Inc
Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation
Terminated
DQYK820009
Mar 29, 2017ReFlow Medical
Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE
Terminated
DQYK141547
Nov 9, 2016Micro Therapeutics Inc, Dba Ev3 Neurovascular
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-8
Terminated
DQYNone listed
Nov 2, 2016Stryker Neurovascular
Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices int
Terminated
DQYK010853
K980453
Nov 2, 2016Stryker Neurovascular
Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devi
Terminated
DQYK010853
K980453
Nov 2, 2016Stryker Neurovascular
Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. 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 90CM, Model number: M003100630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices int
Terminated
DQYK010853
K980453

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