MEDTRONIC VASCULAR

Registration Details

Registration Name: MEDTRONIC VASCULAR
Registration Number: 1220452
FEI Number: 1220452
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 37A Cherry Hill Dr
City: DANVERS
State: MA
ZIP: 01923
Country: US

Regulatory Submissions

510(k) Number: K030671
PMA Number: P010015

Owner / Operator

Firm Name: Medtronic, Inc.
Operator Number: 2112641
Address: 710 Medtronic Parkway
City: Minneapolis
State: MN
Postal Code: 55432
Country: US

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Catheter, Percutaneous	DQY	Class 2	Cardiovascular	No	2012-10-11
Syringe, Balloon Inflation	MAV	Class 2	Cardiovascular	No	2022-04-20
Catheter, Intravascular, Diagnostic	DQO	Class 2	Cardiovascular	No	2012-10-12
Implantable Pulse Generator, Pacemaker (Non-Crt)	LWP	Class 3	Unknown	No	2007-01-23
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	OJX	Class 3	Unknown	No	2007-01-23
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	NKE	Class 3	Unknown	No	2007-01-23
Pulse Generator, Permanent, Implantable	NVZ	Class 3	Unknown	No	2007-01-23
Aspiration Thrombectomy Catheter	QEZ	Class 2	Cardiovascular	No	2004-08-26
Catheter, Continuous Flush	KRA	Class 2	Cardiovascular	No	2004-08-26
Wire, Guide, Catheter	DQX	Class 2	Cardiovascular	No	2011-10-28
Catheter, Embolectomy	DXE	Class 2	Cardiovascular	No	2016-04-11
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	Class 2	Cardiovascular	No	2004-03-09
Catheter, Angioplasty, Peripheral, Transluminal	LIT	Class 2	Cardiovascular	No	2012-10-15

Proprietary Names

7F and 8F Launcher Biopsy Guiding Catheter 7F Launcher Guiding Catheter PWP Catheter 6F Launcher Guiding Catheter Syncra CRT-P Attain Viva CRT-P Solara CRT-P MRI SureScan Percepta CRT-P MRI SureScan Solara Quad CRT-P MRI SureScan Insync Attain Bipolar OTW Lead Consulta CRT-P Percepta Quad CRT-P MRI SureScan Attain OTW Serena CRT-P MRI SureScan Serena Quad CRT-P MRI SureScan CareLink SmartSync Percepta, Solera, Serena Application 6F Sherpa NX Balanced7F Sherpa NX Balanced 7F Export Catheter 6F Sherpa Balance Guiding Catheter Angiography Guide Wires - Multiple Export Advance (new design) 6F Tiaga 5F Taiga 7F Zuma2 Guiding Catheter Piton Y-Pack and Piton Tri-Pak, Torque Handle Y-Connector with modified Touhy-Borst Adaptor, Stretch Insertion Tool Liberant RX Aspiration Catheter 5F and 6F Z2 Guiding Catheter 5F and 8F Launcher Guiding Catheter 8F Zuma2 Guiding Catheter Export XT and AP Catheter Piton Y Adaptor, Piton Tri-Adaptor Launcher Guide Catheters Everest Inflation Device Cougar" Guidewire, Zinger" Guidewire, Thunder" Guidewire, ProVia" Guidewire, Intuition" Guidewire. Angiography Guide Wires (non-teflon coated) ProVia 15 Guidewire (Import for Export) Spring Safety (SOS) Guidewire PTCA Accessory Pack (Y-Adaptor w/Hemostasis Valve, Stretch Insertion Tool, Steering Handle, Sterile Sleeve) PTCA Accessory Pack (Y-Adaptor with Hemostasis Valve, Stretch Insertion Tool) Launcher Guide Catheter Sherpa NX Balanced Guide Catheter 6F Taiga 7F Sherpa Balance Guiding Catheter DxTerity Catheter

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only Repack or Relabel Medical Device