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

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)
Apr 21, 2021	MICROVENTION INC. VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature. Terminated	DQY	K192135
Apr 21, 2021	MICROVENTION INC. VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature. Terminated	DQY	K192135
Mar 5, 2021	Boston Scientific Corporation MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to th Terminated	DQY	K190401
Mar 5, 2021	Boston Scientific Corporation MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are appl Terminated	DQY	K190401
Jan 15, 2021	Medtronic Vascular Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30 Terminated	DQY	K021256
Jan 15, 2021	Medtronic Vascular Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375 Terminated	DQY	K021256
Jan 15, 2021	Medtronic Vascular Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40 Terminated	DQY	K021256
Jan 15, 2021	Medtronic Vascular Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 Terminated	DQY	K021256
Dec 15, 2020	Boston Scientific Corporation ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned. Terminated	DQY	K080154
Oct 1, 2020	Bard Peripheral Vascular Inc Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal Terminated	DQY	K083657
Jun 2, 2020	Cook Inc. Pressure Monitoring Tray, C-PMSY, G02854 Terminated	DQY	None listed
Jun 2, 2020	Cook Inc. Pressure Monitoring Set, C-PMS, G02838 Terminated	DQY	None listed
Dec 20, 2019	Arrow International Inc Arrow Central Venous Catheterization Kit ASK-04200-UPM Terminated	DQY	K820009
Oct 24, 2019	Boston Scientific Corporation Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F. Terminated	DQY	K163314
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5 SH, .070", REF SA6JR45SH. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL355. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.0, .070", REF SA6CHAMP30. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75 SH, .070", REF SA6MAC375SH. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0 SH, .070", REF SA6EBU50SH. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.0, .070", REF SA6SL30. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL205. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F SAR2.0 .070", REF SA6SAR20. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.5, .070", REF SA6CHAMP35. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5, .070", REF SA6SAL15. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL, .070", REF SA6ELGAMAL. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0 SH, .070", REF SA6JR60SH. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5 SH, .070", REF SA6SCR35SH. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5 SH, .070", REF SA6CHAMP15SH. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F JCL4.0, .070", REF SA6JCL40. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB SH, .070", REF SA6LCBSH. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL405. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC5.0, .070", REF SA6MAC50. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT SH, .070", REF SA6ERADLSH. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0, .070", REF SA6ECR40. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT SHORT TIP, .070", REF SA6ERADRST. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0 SH, .070", REF SA6MAC40SH. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR5.0, .070", REF SA6SCR50. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F RELAXED MOD HSII, .070", REF SA6RMHSII. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR3.5, .070", REF SA6ECR35. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 SH, .070", REF SA6MAC30SH. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT, .070", REF SA6ERADR. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL2.0 SH, .070", REF SA6SAL20SH. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F FR3.5, .070", REF SA6FR35. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.0 SH, .070", REF SA6JR30SH. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL3.0, .070", REF SA6SAL30. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0, .070", REF SA6SCR40. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, SHORT TIP, .070", REF SA6ERADLST. for cardiovascular use Terminated	DQY	K042489 K132673
Oct 1, 2019	Medtronic Vascular SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5 SH, .070", REF SA6AL15SH. for cardiovascular use Terminated	DQY	K042489 K132673

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