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Vascular Solution, Inc.

USA · Minneapolis

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, South Korea, Israel — 5 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 67 registration records and 116 510(k), 32 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 2Class II 4

7 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

27 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States67 registration records, 116 510(k), 32 PMA, 125 excluded

Brazil6 confirmed, 14 excluded

Canada11 confirmed, 21 excluded

Manufacturer names merged into this page: VASCULAR SOLUTIONS LLC · VASCULAR SOLUTIONS, LLC · VASCULAR SOLUTIONS INC

FDA 510(k) clearances by year

62004

132005

62006

142007

62008

92009

52010

72011

32012

52014

32015

32016

102017

62018

22019

32020

12021

42022

12023

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	K220647	GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)	2022-08-18
BR	80312279079	OnControl Power Driver	Class II
BR	10350530207	Cateter Turnpike LP	Class II
BR	10350539001	D-STAT HANDLE	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 Solution, 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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