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Contego Medical, Inc.

USA · Santa Clara

✓ 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

4listed device types

Class I 0Class II 3Class III 1

plus 11 registration records and 7 510(k), 9 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

0active device licences

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 States11 registration records, 7 510(k), 9 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: CONTEGO MEDICAL, INC · CONTEGO MEDICAL, LLC

FDA 510(k) clearances by year

22018 · K181529

22022 · K221204

22023 · K230030

12025 · K251485

FDA listed device types

Temporary Carotid Catheter For Embolic Capture 1Peripheral Mechanical Thrombectomy With Aspiration 1Catheter, Angioplasty, Peripheral, Transluminal 1Stent, Carotid 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251485	Excipio LV Prime Thrombectomy Device	2025-06-13
US	K230030	Excipio SV Aspiration Catheter and Tubing	2023-05-30
US	K223897	Excipio LV Thrombectomy Device	2023-02-17
BR	80202910093	Vanguard IEP - Cateter Balão Periférico para Angioplastia com Proteção	Class II

Contego Medical, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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