FDA Registration
Active
🇳🇱 Netherlands
Convey 5F Guiding Catheter
Reg #: 3005635992
·
FEI: 3005635992
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PENDRACARE INTERNATIONAL B.V.
- Registration Number
- 3005635992
- FEI Number
- 3005635992
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Van der Waalspark 22
- City
- Leek Groningen
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K120585
Owner / Operator
- Firm Name
- PendraCare International B.V.
- Operator Number
- 10041705
- Address
- Van der Waalspark 22
- City
- Leek
- State
- NL-NOTA
- Postal Code
- 9351 VC
- Country
- NL
- Correspondent
- Erendira Rodriguez
US Agent
- Business Name
- CORVITEX
- Contact Name
- Tom Nolan
- Address
- 7205 Laketree Dr
- City
- Raleigh
- State
- NC
- ZIP
- 27615
- Country
- US
- [email protected]
- Phone
- 919 8787888
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2012-08-22 |
Proprietary Names
Convey 5F Guiding Catheter
Convey 6F Guiding Catheter
Establishment Types
Manufacture Medical Device