ev3 Inc.
⚠️ Moderate Risk
FEI: 2183870 • Plymouth, MN • UNITED STATES
FEI Number
2183870
Location
Plymouth, MN
Country
UNITED STATESAddress
4600 Nathan Ln N, , Plymouth, MN, United States
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
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
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 |
|---|---|---|---|
| 6/6/2019 | 74NIPSTENT, SUPERFICIAL FEMORAL ARTERY | Division of Southeast Imports (DSEI) | |
| 8/10/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | 508NO 510(K) | Minneapolis District Office (MIN-DO) |
| 8/10/2011 | 74NFADEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTECTION | 508NO 510(K) | Minneapolis District Office (MIN-DO) |
| 8/10/2011 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 508NO 510(K) | Minneapolis District Office (MIN-DO) |
| 8/10/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | 508NO 510(K) | Minneapolis District Office (MIN-DO) |
| 8/10/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | 508NO 510(K) | Minneapolis District Office (MIN-DO) |
| 8/10/2011 | 74LITCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | 508NO 510(K) | Minneapolis District Office (MIN-DO) |
| 8/10/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | 508NO 510(K) | Minneapolis District Office (MIN-DO) |
| 8/10/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | 508NO 510(K) | Minneapolis District Office (MIN-DO) |
| 8/10/2011 | 74MCWCATHETER, PERIPHERAL, ATHERECTOMY | 508NO 510(K) | Minneapolis District Office (MIN-DO) |
| 8/10/2011 | 74LITCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | 508NO 510(K) | Minneapolis District Office (MIN-DO) |
| 8/10/2011 | 74NIMSTENT, CAROTID | 237NO PMA | Minneapolis District Office (MIN-DO) |
| 8/10/2011 | 84NJESTENT, INTRACRANIAL NEUROVASCULAR | 237NO PMA | Minneapolis District Office (MIN-DO) |
| 4/7/2004 | 74DTDADAPTOR, LEAD, PACEMAKER | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is ev3 Inc.'s FDA import refusal history?
ev3 Inc. (FEI: 2183870) has 14 FDA import refusal record(s) in our database, spanning from 4/7/2004 to 6/6/2019.
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. ev3 Inc.'s FEI number is 2183870.
What types of violations has ev3 Inc. received?
ev3 Inc. 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 ev3 Inc. come from?
All FDA import refusal data for ev3 Inc. 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.