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Medtronic Heart Valves

USA · Minneapolis
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
12listed device types
Class I 3Class II 3Class III 4unclassified 2
plus 36 registration records and 3 510(k), 63 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
7registered devices
Class I 6Class II 1
13 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States36 registration records, 3 510(k), 63 PMA
Brazil7 confirmed, 0 excluded
Manufacturer names merged into this page: Medtronic Heart Valves Division · MEDTRONIC HEART VALVES · MEDTRONIC HEART VALVES DIVISION/MEDTRONIC COREVALVE LLC
Same-named companies — This database also contains companies with near-identical names: Medtronic Heart Valves Division. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Minneapolis

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12003 · K032810
12005 · K052860
12006 · K052970

FDA listed device types

showing 8 of 12
Wire, Guide, Catheter 1Electrode, Pacemaker, Temporary 1Ring, Annuloplasty 1Holder, Heart-Valve, Prosthesis 1Instruments, Surgical, Cardiovascular 1Sizer, Heart-Valve, Prosthesis 1Heart-Valve, Non-Allograft Tissue 1Aortic Valve, Prosthesis, Percutaneously Delivered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK052970SIMPLICI-T ANNULOPLASTY SYSTEM2006-01-11
USK052860CG FUTURE ANNULOPLASTY BAND2005-11-10
USK032810DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE2003-12-05
BR10349000603Conjunto de Medidores - Anel Profile 3DClass I
BR10349000617MANÍPULO - ANEL CONTOUR 3DClass I
BR10349000618MANÍPULO - ANEL E BANDA CG FUTUREClass I

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