FDA Registration
Active
🇨🇦 Canada
FlexCath Select
Reg #: 3002648230
·
FEI: 3002648230
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Medtronic CryoCath LP
- Registration Number
- 3002648230
- FEI Number
- 3002648230
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9000 Autoroute Transcanadienne
- City
- Pointe-Claire Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K163268
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
US Agent
- Business Name
- MEDTRONIC, INC.
- Contact Name
- Rashmi Bhushan
- Address
- 8200 Coral Sea St NE, MVS33
- City
- Mounds View
- State
- MN
- ZIP
- 55112
- Country
- US
- [email protected]
- Phone
- 763 6070535
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2017-05-08 |
Proprietary Names
FlexCath Select
Establishment Types
Manufacture Medical Device