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) |
|---|---|---|---|
| Oct 1, 2019 | Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 90CM.070", REF SA6AL10D. for cardiovascular use Terminated |
DQY | K042489 K132673 |
| Oct 1, 2019 | Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular use Terminated |
DQY | K042489 K132673 |
| Oct 1, 2019 | Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use Terminated |
DQY | K042489 K132673 |
| Oct 1, 2019 | Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular use Terminated |
DQY | K042489 K132673 |
| Oct 1, 2019 | Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use Terminated |
DQY | K042489 K132673 |
| Jun 2, 2019 | Stryker 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 |
DQY | K172468 |
| Feb 7, 2019 | Cordis 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 |
DQY | K021593 K143412 +3 |
| Jan 10, 2019 | Arrow International Inc Arrow Two-Lumen Central Venous Catheterization
Set with Blue FlexTip Catheter
Product Code: CD-10802
GTN: 00801902015396 Terminated |
DQY | K862056 |
| Jan 10, 2019 | Arrow International Inc Arrow Two-Lumen Central Venous Catheterization
Kit with Blue FlexTip Catheter
Product Code: AH-11802 (OUS)
GTN: 00801902026132 Terminated |
DQY | K862056 |
| Nov 14, 2018 | Arrow 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 |
DQY | K862056 |
| Nov 13, 2018 | Stryker Neurovascular Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771 Terminated |
DQY | K010954 K112404 |
| Jul 28, 2018 | Stryker Neurovascular FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size) Terminated |
DQY | K153729 |
| May 11, 2018 | Arrow 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 |
DQY | K862056 |
| May 11, 2018 | Bard 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 |
DQY | K103367 |
| May 11, 2018 | Bard 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 |
DQY | K103367 |
| May 2, 2018 | Stryker 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 |
DQY | K152876 |
| Apr 16, 2018 | Cook 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 |
DQY | K091527 |
| Apr 11, 2018 | Arrow International Inc Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900 Terminated |
DQY | K843263 |
| Apr 11, 2018 | Arrow International Inc 8Fr. Catheter Clamp with Fastener; Product Code: CC-00008 Terminated |
DQY | K820648 |
| Apr 11, 2018 | Arrow International Inc 7Fr. Catheter Clamp with Fastener; Product Code: CC-00007 Terminated |
DQY | K820648 |
| Apr 11, 2018 | Arrow International Inc 5Fr. Catheter Clamp with Fastener; Product Code: CC-00005 Terminated |
DQY | K820648 |
| Apr 11, 2018 | Arrow International Inc 4Fr. Catheter Clamp with Fastener; Product Code: CC-00004 Terminated |
DQY | K820648 |
| Apr 11, 2018 | Arrow 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 |
DQY | K862056 |
| Apr 11, 2018 | Arrow International Inc Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP Terminated |
DQY | K862056 |
| Apr 11, 2018 | Arrow International Inc Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ Terminated |
DQY | K820009 |
| Apr 11, 2018 | Arrow International Inc Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF Terminated |
DQY | K021120 |
| Apr 11, 2018 | Arrow International Inc Maximal Barrier Drape; Product Code: ASK-04000-HMC Terminated |
DQY | K862056 |
| Apr 11, 2018 | Arrow International Inc Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418 Terminated |
DQY | K810962 |
| Mar 29, 2018 | Medtronic Inc 6F Taiga Guiding Catheter Terminated |
DQY | K083422 |
| Mar 7, 2018 | SPS Sterilization, Inc Vascular Solutions Venture Rx Catheter, 6F, resterilized. Terminated |
DQY | K042910 |
| Feb 20, 2018 | Arrow International Inc Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018 Terminated |
DQY | K862056 |
| Feb 20, 2018 | Arrow International Inc Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018 Terminated |
DQY | K862056 |
| Feb 20, 2018 | Arrow 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 |
DQY | K862056 |
| Feb 20, 2018 | Arrow International Inc Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018 Terminated |
DQY | K862056 |
| Feb 20, 2018 | Arrow 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 |
DQY | K862056 |
| Dec 22, 2017 | Arrow 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 |
DQY | K862056 |
| Dec 22, 2017 | Arrow 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 |
DQY | K820009 |
| Dec 11, 2017 | Boston 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 |
DQY | K010853 K980453 |
| Oct 13, 2017 | Cook Inc. Femoral Artery Pressure Monitoring Set Terminated |
DQY | None listed |
| Oct 13, 2017 | Cook Inc. Left Atrial Catheter Set Terminated |
DQY | None listed |
| Oct 13, 2017 | Cook Inc. Central Venous Catheter Tray Terminated |
DQY | None listed |
| May 22, 2017 | Vascular 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 |
DQY | K040922 K042910 +1 |
| May 9, 2017 | Arrow 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 |
DQY | K862056 |
| May 9, 2017 | Arrow 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 |
DQY | K820009 |
| Mar 29, 2017 | ReFlow Medical Wingman 35 Crossing Catheter, 65cm,
Model Numbers:
WGM35065US
WGM35065CE
WGM35090US
WGM35090CE
WGM35135US
WGM35135CE Terminated |
DQY | K141547 |
| Nov 9, 2016 | Micro 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 |
DQY | None listed |
| Nov 2, 2016 | Stryker 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 |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker 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 |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker 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 |
DQY | K010853 K980453 |
| Nov 2, 2016 | Stryker 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 |
DQY | K010853 K980453 |
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