Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1220452

FEI Number

1220452

Entity Name

MEDTRONIC VASCULAR

City/State/Country

DANVERS, MA, US

Establishment Address

37A Cherry Hill Dr, DANVERS, MA 01923, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140695

PMA Number

N/A

All Registered 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 Attain 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.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-10-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-10-11
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2022-04-20
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-10-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-10-11
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2007-01-23
OJX	Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	Unknown	Class 3	N/A	2007-01-23
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2007-01-23
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2007-01-23
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-09-27
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2004-08-26
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2004-08-26
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	1995-01-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-10-28
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-04-08
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2016-04-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-03-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-10-11
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2004-03-09
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-10-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-03-12
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2026-04-24
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-04-24
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-10-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-10-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-10-11
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2012-10-11
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2012-10-11
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-10-15
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-07-03
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2016-05-02
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-08-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007042319	HeartWare, Inc.	Miami Lakes, FL, US
3004497303	MEDTRONIC MEXICO EG	EMPALME Sonora, MX
3015192387	CATHWORKS	Newport Beach, CA, US
3004185781	Medtronic, Inc.	Tempe, AZ, US
3012520654	MEDTRONIC, INC.	Billerica, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1220452. Last updated year: 2026. Please use registration number 1220452 when referencing this establishment in official correspondence.