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Intervascular, Inc.

France · La Ciotat

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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 1Class II 3Class III 0

plus 13 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

6active device licences

Class II 2Class IV 4

17 including historic records

TWTaiwanTFDA

5valid device licences

Class II 5

SGSingaporeHSA SMDR

9device registrations

CLASS D 9

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

11active ARTG entries

Class III 11

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

3active registrations

Class 3 3

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 States13 registration records, 20 510(k), 0 PMA

Brazil0 confirmed, 1 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: Intervascular SAS · INTERVASCULAR SAS

FDA 510(k) clearances by year

11984

21986

21988

11990

41991

11992

21997

11998

11999

12001

22002

12005

12011

FDA listed device types

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene 1Graft, Vascular, Synthetic/Biologic Composite 1Prosthesis, Vascular Graft, Of 6mm And Greater Diameter 1Instruments, Surgical, Cardiovascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K103347	CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES	2011-02-02
US	K042984	INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C	2005-02-18
US	K022242	INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER	2002-08-14
CA	9829	ULTRA LOW POROSITY VASCULAR PROSTHESIS	Class IV
CA	10336	LP200 (LOW POROSITY) WOVEN VASCULAR PROSTHESIS	Class IV
CA	10339	OSCHNER 200 WOVEN VASCULAR PROSTHESIS	Class IV