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Micro Therapeutics, Inc.

USA · Irvine

✓ 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

19listed device types

Class I 0Class II 14Class III 4unclassified 1

plus 150 registration records and 91 510(k), 52 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

33 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

13active device licences

Class II 12Class IV 1

41 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 States150 registration records, 91 510(k), 52 PMA, 114 excluded

Brazil1 confirmed, 23 excluded

Saudi Arabia0 confirmed, 4 excluded

Canada13 confirmed, 8 excluded

Manufacturer names merged into this page: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR · MICRO THERAPEUTICS INC. DBA EV3 NEUROVASCULAR · DENDRON GMBH A SUBSIDIARY OF MICRO THERAPEUTICS, INC. · MICRO THERAPEUTICS, INC. / DBA EV3 NEUROVASCULAR · MICRO THERAPEUTICS, INC., DBA EV3 NEUROVASCULAR · MICRO THERAPEUTICS INC

FDA 510(k) clearances by year

52004

32005

22006

12007

12008

22009

12010

42012

12013

22014

42015

32016

42017

62018

22019

52020

52021

12023

32024

12025

FDA listed device types

showing 8 of 19

Catheter, Continuous Flush 1Guide, Wire, Catheter, Neurovasculature 1Apparatus, Suction, Ward Use, Portable, Ac-Powered 1Wire, Guide, Catheter 1Tube, Aspirating, Flexible, Connecting 1Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment 1Catheter, Intravascular, Diagnostic 1Catheter, Thrombus Retriever 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241388	Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter	2025-01-02
US	K243418	Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing	2024-12-02
US	K243080	Riptide Aspiration System	2024-10-29
BR	10349000597	Destacador Instantâneo	Class I
CA	1857	INFUSION WIRES	Class II
CA	1858	PERIPHERAL MICRO CATHETERS	Class II
CA	96314	ARC INTRACRANIAL SUPPORT CATHETER	Class IV

Micro Therapeutics, 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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