HomeMexicoCardiva Medical, Inc.

Cardiva Medical, Inc.

Mexico · Santa Clara
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 3 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
3listed device types
Class I 0Class II 2Class III 1
plus 3 registration records and 7 510(k), 43 PMA
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
1active device licences
Class II 1
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class III 2
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 States3 registration records, 7 510(k), 43 PMA
Saudi Arabia0 confirmed, 2 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: Cardiva Medical, Inc. · CARDIVA MEDICAL INC.

Company information

Country
Mexico
City
Santa Clara

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

12004 · K041486
22006 · K051817
22007 · K072297
12009 · K082930
12013 · K130124

FDA listed device types

Wire, Guide, Catheter 1Transducer, Pressure, Catheter Tip 1Device, Hemostasis, Vascular 1

Registration details (sample)

MarketIdentifierNameClass / date
USK130124CATALYST II AND III2013-03-14
USK082930CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE2009-02-13
USK072297BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM2007-09-12
CA63120BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM (VCS)Class II

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