FDA Registration
Active
🇳🇱 Netherlands
PENDRACARE INTERNATIONAL B.V.
Reg #: 3005635992
·
FEI: 3005635992
·
Expires 2026
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PENDRACARE INTERNATIONAL B.V.
- Registration Number
- 3005635992
- FEI Number
- 3005635992
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Van der Waalspark 22
- City
- Leek Groningen
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K132197
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 Corporation
- 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 | 2013-08-19 |
Proprietary Names
Convey 7F Guiding Catheter
Convey 8F Guiding Catheter
Climber Hydrophilic Guiding Catheter
Primum Hydrophilic Guiding Catheter
Convey 5F Guiding Catheter
Convey 6F Guiding Catheter
Establishment Types
Manufacture Medical Device