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Home›USA›Cardiac Assist, Maquet Cardiovascular, LLC

Cardiac Assist, Maquet Cardiovascular, LLC

USA · Manwah
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
10listed device types
Class I 4Class II 6Class III 0
plus 16 registration records and 16 510(k), 12 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
6 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
16active device licences
Class II 4Class III 3Class IV 9
30 including historic records
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 States16 registration records, 16 510(k), 12 PMA, 16 excluded
Brazil1 confirmed, 10 excluded
Saudi Arabia0 confirmed, 6 excluded
Canada16 confirmed, 4 excluded
Manufacturer names merged into this page: Maquet Cardiovascular LLC · MAQUET CARDIOVASCULAR LLC
Same-named companies — This database also contains companies with near-identical names: Maquet Cardiovascular, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Manwah

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

12008
12009
12010
22011
12012
22013
22016
12019
12020
12024
22025
12026

FDA listed device types

showing 8 of 10
Stabilizer, Heart 1Catheter, Irrigation 1Instruments, Surgical, Cardiovascular 1Cutter, Surgical 1Electrosurgical, Cutting & Coagulation & Accessories 1Prosthesis, Vascular Graft, Of Less Then 6mm Diameter 1Laparoscope, General & Plastic Surgery 1Lavage, Jet 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252445Fusion Bioline Vascular Graft2026-04-27
USK251238Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)2025-05-30
USK243918Vasoview Hemopro 3 Power Supply2025-02-26
BR80259110169Mecanismo de Acionamento Ultima Activator IIClass I
CA1387HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFTClass IV
CA1398MICROVEL DOUBLE VELOUR GRAFT WITH GUIDELINEClass III
CA1454HEMASHIELD WOVEN DOUBLE VELOUR CARDIOVASCULAR FABRICClass IV

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