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Vascular Solutions, Inc.

USA · Minneapolis

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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

28listed device types

Class I 4Class II 21Class III 2unclassified 1

plus 69 registration records and 125 510(k), 32 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 4Class II 4

9 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

11active device licences

Class II 7Class III 1Class IV 3

28 including historic records

TWTaiwanTFDA

6valid device licences

Class II 6

SGSingaporeHSA SMDR

4device registrations

CLASS D 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

15active ARTG entries

Class III 11IIa 4

HKHong KongMDACS

4valid listings

Class II 2Class IV 2

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 3 1

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 States69 registration records, 125 510(k), 32 PMA, 121 excluded

Brazil8 confirmed, 13 excluded

Canada11 confirmed, 20 excluded

Manufacturer names merged into this page: VASCULAR SOLUTIONS LLC · VASCULAR GRAFT SOLUTIONS · VASCULAR SOLUTIONS ZERUSA LIMITED · VASCULAR SOLUTIONS, LLC · VASCULAR GRAFT SOLUTIONS LTD · VASCULAR SOLUTIONS INC

FDA 510(k) clearances by year

62004

132005

62006

142007

102008

112009

52010

72011

42012

52014

32015

32016

102017

62018

22019

32020

22021

42022

22023

12024

FDA listed device types

showing 8 of 28

Catheter, Intravascular, Diagnostic 1Clamp, Vascular 1Catheter, Conduction, Anesthetic 1Catheter, Continuous Flush 1System, Imaging, Pulsed Doppler, Ultrasonic 1Anesthesia Conduction Kit 1Powered Laser Surgical Instrument 1Catheter Introducer Kit 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233729	Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58	2024-05-31
US	K230637	Wattson temporary pacing guidewire (2250)	2023-05-05
US	K230248	VIOLA	2023-02-28
BR	80312279079	OnControl Power Driver	Class II
BR	10350530207	Cateter Turnpike LP	Class II
BR	80015970028	Selection Tool	Class I
CA	20945	SMARTNEEDLE VASCULAR ACCESS SYSTEM	Class III
CA	65303	AUTO-FILL SYRINGE KIT	Class II
CA	66398	MICRO-INTRODUCER KIT	Class II

Vascular Solutions, 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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