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Home›USA›Cardiacassist, Inc.

Cardiacassist, Inc.

USA · Arvada
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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
21510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 21 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class II 1Class III 1Class IV 1
TWTaiwanTFDA
pendingnot queried
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 States0 registration records, 21 510(k), 0 PMA
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: CARDIACASSIST LLC

Company information

Country
USA
City
Arvada

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

12000
12003
22006
12008
12011
12012
32014
32016
12017
12018
12019
12021
12022
22023
12024

Registration details (sample)

MarketIdentifierNameClass / date
USK233736LifeSPARC System2024-01-19
USK232480ProtekDuo Veno-Venous Cannula Sets2023-10-06
USK232132LifeSPARC System2023-08-03
CA92872TANDEMHEART SYSTEMClass IV
CA93639PROTEK CANNULA SETClass II
CA108465LIFESPARC SYSTEMClass III

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