Medtronic CryoCath LP
⚠️ Moderate Risk
FEI: 3002648230 • Montreal, Quebec • CANADA
FEI Number
3002648230
Location
Montreal, Quebec
Country
CANADAAddress
9000 Chemin De Service S, , Montreal, Quebec, Canada
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).
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 |
|---|---|---|---|
| 4/19/2017 | 74OAECATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/19/2017 | 74OAECATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/5/2008 | 74OBXCATHETER, CORONARY, ACUTE MYOCARDIAL INFARCTION, TEMPORARY, FOR EMBOLIZATION PROTECTION | 341REGISTERED | Detroit District Office (DET-DO) |
| 9/5/2008 | 74OBXCATHETER, CORONARY, ACUTE MYOCARDIAL INFARCTION, TEMPORARY, FOR EMBOLIZATION PROTECTION | 341REGISTERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Medtronic CryoCath LP's FDA import refusal history?
Medtronic CryoCath LP (FEI: 3002648230) has 4 FDA import refusal record(s) in our database, spanning from 9/5/2008 to 4/19/2017.
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. Medtronic CryoCath LP's FEI number is 3002648230.
What types of violations has Medtronic CryoCath LP received?
Medtronic CryoCath LP has been cited for 2 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 Medtronic CryoCath LP come from?
All FDA import refusal data for Medtronic CryoCath LP 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.