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Medtronic Vascular, Inc.

USA · Santa Rosa

✓ 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

21listed device types

Class I 1Class II 11Class III 9

plus 50 registration records and 483 510(k), 829 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

2active device licences

Class IV 2

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 States50 registration records, 483 510(k), 829 PMA, 123 excluded

Brazil0 confirmed, 16 excluded

Canada2 confirmed, 21 excluded

Manufacturer names merged into this page: Medtronic Vascular · MEDTRONIC VASCULAR · MEDTRONIC AVE (ARTERIAL VASCULAR ENGINEERING INC.

FDA 510(k) clearances by year

182001

142002

152003

162004

52005

82006

42007

12008

32009

12010

22013

12014

52016

32017

22018

12019

12020

12022

32023

12026

FDA listed device types

showing 8 of 21

Catheter, Continuous Flush 1Endovascular Suturing System 1Wire, Guide, Catheter 1Syringe, Balloon Inflation 1Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 1Catheter, Angioplasty, Peripheral, Transluminal 1Catheter, Intravascular, Diagnostic 1Aspiration Thrombectomy Catheter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253589	Liberant RX Aspiration Catheter	2026-04-23
US	K232570	Steerant Super Stiff Guidewire	2023-10-24
US	K232190	6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter	2023-08-22
CA	9270	AVELTX PTCA BALLOON DILATATION CATHETER	Class IV
CA	10654	MICRO STENT II RAPID EXCHANGE DELIVERY SYSTEM AND MICRO STENT II XL RAPID EXCHANGE DELIVERY SYSTEM	Class IV

Medtronic Vascular, 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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