Abbott Vascular Netherlands B.V.
⚠️ Moderate Risk
FEI: 3008992085 • Heerlen, Limburg • NETHERLANDS
FEI Number
3008992085
Location
Heerlen, Limburg
Country
NETHERLANDSAddress
Arendstraat 1, , Heerlen, Limburg, Netherlands
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/20/2013 | 74NIQSTENT, CORONARY, DRUG-ELUTING | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/20/2013 | 74NIQSTENT, CORONARY, DRUG-ELUTING | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/12/2013 | 74NIQSTENT, CORONARY, DRUG-ELUTING | Division of Southeast Imports (DSEI) | |
| 12/12/2013 | 74NIQSTENT, CORONARY, DRUG-ELUTING | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Abbott Vascular Netherlands B.V.'s FDA import refusal history?
Abbott Vascular Netherlands B.V. (FEI: 3008992085) has 4 FDA import refusal record(s) in our database, spanning from 12/12/2013 to 12/20/2013.
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. Abbott Vascular Netherlands B.V.'s FEI number is 3008992085.
What types of violations has Abbott Vascular Netherlands B.V. received?
Abbott Vascular Netherlands B.V. has been cited for 3 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 Abbott Vascular Netherlands B.V. come from?
All FDA import refusal data for Abbott Vascular Netherlands B.V. 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.