Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1640201

FEI Number

3002707083

Entity Name

Intervascular SAS

City/State/Country

LA CIOTAT Bouches-du-Rhone, FR

Establishment Address

ZI Athelia 1, 270 voie Ariane, LA CIOTAT Bouches-du-Rhone 13600, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Maquet Cardiovascular LLC (Owner Number: 10024202)

Owner / Operator Contact Address

45 Barbour Pond Drive, Wayne, NJ 07470, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K103347

PMA Number

N/A

All Registered Proprietary Names

HemaCarotid Patch InterGard Knitted HemaPatch Hemagard Carotid patch Hemagard Knitted Polyester Tape InterGard Knitted UltraThin HemaCarotid UltraThin Patch Hemagard Knitted UltraThin Hemagard Carotid Patch UltraThin InterGard HemaBridge InterGard Aortic Arch Graft Sizer HEMASHIELD Maquet Cardioroot Vascular Graft Intervascular Cardioroot Vascular Graft Intergard Cardioroot Woven Vascular Graft

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2010-12-02
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2008-01-22
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2010-12-02
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2010-12-02
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2008-01-22
MAL	Graft, Vascular, Synthetic/Biologic Composite	Cardiovascular	Class 2	870.3450	2008-01-22
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2011-02-14

Official Correspondent

No official correspondent registered.

US Agent Details

Emily Valerio Email: emily.valerio@getinge.com Phone: (862) 2215193

Related Public Records

Same Entity

Maquet Cardiovascular LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2242352	Maquet Cardiovascular LLC	Wayne, NJ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962639	Impra, Inc.	IMPRA CARBOFLO EPTFE VASCULAR GRAFT	1996-10-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2026	W L Gore & Associates, Inc.	2	GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

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3006950086	Merit Medical Nederland BV	Maastricht Airport Limburg, NL
3010097171	Millstone Medical Outsourcing LLC	Olive Branch, MS, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1640201. Last updated year: 2026. Please use registration number 1640201 when referencing this establishment in official correspondence.