INTERVASCULAR, SAS
⚠️ High Risk
FEI: 3002707083 • La Ciotat Cedex, Bouches du Rhone • FRANCE
FEI Number
3002707083
Location
La Ciotat Cedex, Bouches du Rhone
Country
FRANCEAddress
1 Zone Industrielle Athelia, , La Ciotat Cedex, Bouches du Rhone, France
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/13/2025 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/13/2025 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/13/2025 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/13/2025 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/13/2025 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/13/2025 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/13/2025 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/13/2025 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/13/2025 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/13/2025 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/13/2025 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/2/2025 | 74MALGRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE | Division of Southeast Imports (DSEI) | |
| 12/11/2024 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/11/2024 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/11/2024 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/11/2024 | 74DXZPATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 74DYEHEART-VALVE, REPLACEMENT | Division of Southeast Imports (DSEI) | |
| 2/22/2018 | 74DYEHEART-VALVE, REPLACEMENT | Division of Southeast Imports (DSEI) | |
| 2/22/2018 | 74DYEHEART-VALVE, REPLACEMENT | Division of Southeast Imports (DSEI) | |
| 2/22/2018 | 74DYEHEART-VALVE, REPLACEMENT | Division of Southeast Imports (DSEI) | |
| 2/22/2018 | 74DYEHEART-VALVE, REPLACEMENT | Division of Southeast Imports (DSEI) | |
| 6/30/2017 | 74MALGRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is INTERVASCULAR, SAS's FDA import refusal history?
INTERVASCULAR, SAS (FEI: 3002707083) has 22 FDA import refusal record(s) in our database, spanning from 6/30/2017 to 5/13/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. INTERVASCULAR, SAS's FEI number is 3002707083.
What types of violations has INTERVASCULAR, SAS received?
INTERVASCULAR, SAS has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about INTERVASCULAR, SAS come from?
All FDA import refusal data for INTERVASCULAR, SAS is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.