Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008592544

FEI Number

3008592544

Entity Name

Medtronic, Inc. (Minneapolis, MN 55447)

City/State/Country

Minneapolis, MN, US

Establishment Address

3800 ANNAPOLIS LANE, Minneapolis, MN 55447, US

Establishment Type(s)

Manufacture Medical Device

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

N/A

PMA Number

P990046

All Registered Proprietary Names

Open Pivot Handle TriAd Handle CG Future Handle Profile 3D Handle Enable Folding System Open Pivot Rotator Duran Ancore Handle Open Pivot Holder HEART-VALVE Contour 3D Handle Simulus Handle Threaded or Valve handle Avalus Valve Handle PROSTHESIS HOLDER MITRAL COLLAR AND TIE Actuators Rotation Tool Kit AORTIC CUFF Universal Mounting Rail pinch on tool MEDIUM BLADE SET TOOL Lead Accessory Kit Adjustable Slitter Implant Tool Kit ATRIAL LIFT SYSTEM Accessory Port ATS Medical Thoracic Port System EXTRA LG BLADE SET TOOL INTERCOSTAL RETRACTOR SYSTEM SUTURE BELT LARGE BLADE SET TOOL STERILIZATION TRAY TOOL RETRACTOR RACK TOOL SMALL BLADE SET TOOL Mounting Rail Universal II Slitter MHV ATS Open Pivot Aortic Valved Graft ATS Open Pivot Bi-leaflet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTJ	Holder, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3935	1992-07-30
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1992-12-02
LWQ	Heart-Valve, Mechanical	Unknown	Class 3	N/A	2010-09-07

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
K813276	Shiley, Inc.	IONESCU-SHILEY VALVE HOLDER & HANDLE	1981-12-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

Similar Registrations

Registration Number	Establishment Name	Location
2135147	Abbott Medical	Plymouth, MN, US
3005687633	Corcym S.r.l.	SALUGGIA Vercelli, IT
2133928	Metal Craft Machine & Engineering, Inc.	Elk River, MN, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
2025587	Medtronic Heart Valves Division	Santa Ana, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008592544. Last updated year: 2026. Please use registration number 3008592544 when referencing this establishment in official correspondence.