Company · US

Medtronic Vascular

FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2023. Name variants (Inc, Corp, punctuation) are merged.

480510(k) clearances (0 in 12 months)

234recalls (0 in 12 months)

214recalls that name a 510(k)

Product codes

Code	Device	Records
DQY	Catheter, Percutaneous	229
DTB	Permanent Pacemaker Electrode	69
DXY	Implantable Pacemaker Pulse-Generator	59
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	56
LDF	Electrode, Pacemaker, Temporary	21
DTD	Pacemaker Lead Adaptor	19
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	15
DTZ	Oxygenator, Cardiopulmonary Bypass	12
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	11
GXY	Electrode, Cutaneous	10
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	10
DQX	Wire, Guide, Catheter	9
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	8
DYB	Introducer, Catheter	7
DRX	Electrode, Electrocardiograph	6
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	6
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	5
DTC	Analyzer, Pacemaker Generator Function	5
DTE	Pulse-Generator, Pacemaker, External	5
DTN	Reservoir, Blood, Cardiopulmonary Bypass	5

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Oct 24, 2023	K232570	Steerant Super Stiff Guidewire Medtronic Vascular	DQX
Aug 22, 2023	K232190	6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter Medtronic Vascular	DQY
Jun 30, 2023	K230156	5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter Medtronic Vascular	DQY
Apr 13, 2022	K220773	Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest Medtronic Vascular	MAV
Sep 20, 2019	K192296	Medtronic 6F Taiga Guiding Catheter Medtronic Vascular	DQY
Nov 21, 2018	K182957	Heli-FX EndoAnchor System Medtronic Vascular, Inc.	OTD
Apr 12, 2018	K173515	Admiral Xtreme Medtronic Vascular	LIT
Dec 20, 2017	K171866	Sentrant Introducer Sheath with Hydrophilic Coating Medtronic Vascular, Inc.	DYB
Jun 16, 2017	K170191	SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System Medtronic Vascular, Inc.	MCW
Jun 13, 2017	K171427	Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette Medtronic Vascular, Inc.	OTD
Nov 17, 2016	K162097	InTRAkit Medtronic Vascular	DYB
Oct 21, 2016	K162027	TRAcelet Compression Device Medtronic Vascular	DXC
Oct 14, 2016	K161361	HawkOne Directional Atherectomy System Medtronic Vascular, Inc.	MCW
Aug 19, 2016	K161287	DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak Medtronic Vascular	DQO
Mar 26, 2014	K133539	TOTAL ACROSS Medtronic Vascular	DQY
Apr 26, 2013	K123990	SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING Medtronic Vascular	DYB
Jan 29, 2013	K123358	PACIFIC PLUS Medtronic Vascular	LIT
Jul 23, 2010	K101777	PIONEER PLUS CATHETER, MODEL PLUS 120 Medtronic Vascular	PDU
Dec 4, 2009	K091582	GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 Medtronic Vascular	DQX
Feb 6, 2009	K083422	6F TAIGA GUIDING CATHETER Medtronic Vascular	DQY
Feb 6, 2009	K082873	MEDTRONIC ANGIOGRAPHIC GUIDE WIRES Medtronic Vascular	DQX
Jun 27, 2008	K081573	MEDTRONIC EXPORT AP CATHETER Medtronic Vascular	DXE
Nov 8, 2007	K062264	COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM Medtronic Vascular	FGE
Jul 3, 2007	K071253	AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 Medtronic Vascular	DTM
Jun 18, 2007	K070288	CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814 Medtronic Vascular	OCL
Apr 24, 2007	K070311	CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 Medtronic Vascular	GEI
Oct 25, 2006	K061416	SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74 Medtronic Vascular	DQY
Oct 11, 2006	K062727	CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE Medtronic Vascular	GCJ
Sep 8, 2006	K062420	5F SHERPA ACTIVE NX GUIDE CATHETER Medtronic Vascular	DQY
Sep 5, 2006	K061958	MEDTRONIC EXPORT XT CATHETER Medtronic Vascular	QEZ
Aug 2, 2006	K062057	U-CLIP DEVICE, MODEL NC65 Medtronic Vascular	FZP
May 23, 2006	K061127	CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R Medtronic Vascular	KRH
Mar 15, 2006	K060418	8F SHERPA NX GUIDE CATHETER Medtronic Vascular	DQY
Jan 11, 2006	K052459	6248VAL ADJUSTABLE VALVE Medtronic Vascular	DTL
Dec 16, 2005	K053252	U-CLIP DEVICE, MODELS B140, B160 AND B180 Medtronic Vascular	FZP
Dec 16, 2005	K051386	MASTERGRAFT PUTTY BONE VOID FILLER Medtronic Vascular	MQV
Nov 17, 2005	K052413	TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 Medtronic Vascular	KNS
Aug 5, 2005	K051846	7F SHERPA NX GUIDE CATHETER Medtronic Vascular	DQY
Mar 22, 2005	K050139	MODIFICATION TO: EXPORT CATHETER Medtronic Vascular	QEZ
Dec 21, 2004	K043291	CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884 Medtronic Vascular	GEI
Dec 13, 2004	K042489	6F Z4 GUIDE CATHETER Medtronic Vascular	DQY
Dec 3, 2004	K043080	HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR Medtronic Vascular	JOX
Oct 18, 2004	K042206	PURPLE/BLACK HEPARIN ASSAY CONTROL Medtronic Vascular	GGN
Oct 18, 2004	K042175	HEPARINASE HR ACT CONTROL, MODEL 550-12 Medtronic Vascular	GGN
Oct 1, 2004	K042070	HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 Medtronic Vascular	JOX
Sep 15, 2004	K042194	ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY Medtronic Vascular	DQY
Sep 7, 2004	K042190	MODEL 6416 TEMPORARY PACING LEAD SYSTEM Medtronic Vascular	LDF
Sep 2, 2004	K040812	DETECT SURGICAL PACING AND MAPPING TOOL Medtronic Vascular	LDF
Aug 12, 2004	K041244	POLYGRAM NET BIOFEEDBACK APPLICATION Medtronic Vascular	HCC
Jul 19, 2004	K041338	MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES Medtronic Vascular	MWS

Newest 50 of 480.

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Mar 23, 2022	Medtronic Vascular, Inc. Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only Open, Classified	PRC	None listed
Mar 23, 2022	Medtronic Vascular, Inc. Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM04012013P ADM04015013P ADM Open, Classified	ONU	None listed
Dec 21, 2021	Medtronic Vascular, Inc. Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145 Open, Classified	MIH	None listed
Oct 15, 2021	Medtronic Vascular, Inc. Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103 Open, Classified	MIH	None listed
Oct 15, 2021	Medtronic Vascular, Inc. Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE Open, Classified	MIH	None listed
Oct 15, 2021	Medtronic Vascular, Inc. Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE Open, Classified	MIH	None listed
Jun 16, 2021	Medtronic Vascular Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that fur Terminated	NKQ	None listed
Jun 7, 2021	Medtronic Vascular, Inc. Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using a Open, Classified	MIH	None listed
Jun 7, 2021	Medtronic Vascular, Inc. Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aort Open, Classified	MIH	None listed
Apr 28, 2021	Medtronic Vascular, Inc. Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms. Terminated	MIH	None listed
Feb 12, 2021	Medtronic Vascular, Inc. Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA). Open, Classified	MIH	None listed
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
Oct 16, 2020	Medtronic Vascular Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind balloon septostomy catheters are designed for creating an Terminated	DXF	None listed
Oct 16, 2020	Medtronic Vascular Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashkind balloon septostomy catheters are designed for creating an Terminated	DXF	None listed
Oct 16, 2020	Medtronic Vascular Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 The Rashkind balloon septostomy catheters are designed Terminated	DXF	None listed
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

Newest 50 of 234.

Get alerts for these product codes