Cardio Valve Technologies
⚠️ Moderate Risk
FEI: 3010114745 • Irvine, CA • UNITED STATES
FEI Number
3010114745
Location
Irvine, CA
Country
UNITED STATESAddress
2 Jenner Ste 100, , Irvine, CA, 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
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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/22/2015 | 74LPBCARDIAC ABLATION PERCUTANEOUS CATHETER | New Orleans District Office (NOL-DO) | |
| 4/22/2015 | 74LPBCARDIAC ABLATION PERCUTANEOUS CATHETER | New Orleans District Office (NOL-DO) | |
| 4/22/2015 | 74LPBCARDIAC ABLATION PERCUTANEOUS CATHETER | New Orleans District Office (NOL-DO) | |
| 4/22/2015 | 74MAFSTENT, CARDIOVASCULAR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Cardio Valve Technologies's FDA import refusal history?
Cardio Valve Technologies (FEI: 3010114745) has 4 FDA import refusal record(s) in our database, spanning from 4/22/2015 to 4/22/2015.
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. Cardio Valve Technologies's FEI number is 3010114745.
What types of violations has Cardio Valve Technologies received?
Cardio Valve Technologies 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 Cardio Valve Technologies come from?
All FDA import refusal data for Cardio Valve Technologies 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.