Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2025587

FEI Number

2025587

Entity Name

Medtronic Heart Valves Division

City/State/Country

Santa Ana, CA, US

Establishment Address

1851 EAST DEERE AVE., Santa Ana, CA 92705, 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

K052565

PMA Number

N/A

All Registered Proprietary Names

Simulus Flexible Annuloplasty Band CoreValve Evolut PRO System Medtronic CoreValve System CoreValve Evolut R System CoreValve Evolut PRO+ System Evolut FX+ System Medtronic Evolut FX System Profile 3D Annuloplasty Ring Stedi Extra Support Guidewire CG Future Band Simplici-T SimuPlus, SimuForm Confida Brecker Curve Guidewire Simulus Adjustable Annuloplasty Ring 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 Tri-Ad Adams Annuloplasty Ring Hancock II ULTRA Supra-X Aortic Sizers TriAd sizers Contour 3D sizers Mosaic Ultra Supra-X Aortic Sizers CG Future Sizers Hancock II Aortic and Mitral Obturators Simulus Sizers Avalus Sizers Open Pivot sizers Profile 3D Ring Sizers Mosaic Aortic and Mitral Obturators Freestyle Obturators Duran Ancore Sizers Mosaic Neo Streamline Temporary Pacing Leads Confida Brecker Curve Guidewire CG Future Ring Mosaic ULTRA Mosaic Mosaic Neo Hancock M.O. Hancock Modified Orifice Hancock MO Avalus bioprosthesis Duran Ancore Band Duran Ancore Ring Hancock Bioprosthesis Contegra Simulus Adjustable Annuloplasty Band Tri-Ad Adams Annuloplasty Ring Simulus Flexible Annuloplasty Ring

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2011-06-17
NPT	Aortic Valve, Prosthesis, Percutaneously Delivered	Unknown	Class 3	N/A	2014-01-17
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2008-06-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-06-18
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2007-12-28
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2007-12-27
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2020-07-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-12-24
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2011-06-17
DTJ	Holder, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3935	1992-07-30
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2011-06-17
DTI	Sizer, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3945	1992-07-30
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2017-11-01
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-05-04
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2007-12-28
DYE	Replacement Heart-Valve	Cardiovascular	Class 3	870.3925	2007-12-27
LWR	Heart-Valve, Non-Allograft Tissue	Unknown	Class 3	N/A	2007-12-27
LWR	Heart-Valve, Non-Allograft Tissue	Unknown	Class 3	N/A	2007-12-27
LWR	Heart-Valve, Non-Allograft Tissue	Unknown	Class 3	N/A	2017-08-04
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2007-12-28
DYE	Replacement Heart-Valve	Cardiovascular	Class 3	870.3925	2009-04-01
DYE	Replacement Heart-Valve	Cardiovascular	Class 3	870.3925	2007-12-27
MWH	Pulmonic Valved Conduit	Unknown	Class f	N/A	2007-12-27
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2011-06-17
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2018-07-18
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2011-06-17

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
K253232	ABBOTT MEDICAL	Seguin Annuloplasty Ring	2025-10-29
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0491-2025	Abbott Medical	3	Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Z-0492-2025	Abbott Medical	3	Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Z-0493-2025	Abbott Medical	3	Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
Z-0494-2025	Abbott Medical	3	Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Z-0495-2025	Abbott Medical	3	Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile

Similar Registrations

Registration Number	Establishment Name	Location
2135147	Abbott Medical	Plymouth, MN, US
3007113487	Abbott Medical	Saint Paul, MN, US
2029275	Sterigenics U.S., LLC	Corona, CA, US
1720929	ISOMEDIX OPERATIONS INC.	Sandy, UT, US
9617601	Medtronic Mexico S. de R.L. de CV	Tijuana Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2025587. Last updated year: 2026. Please use registration number 2025587 when referencing this establishment in official correspondence.