FDA Registration
Active
🇺🇸 United States
Turnpike Catheter (135 cm),Turnpike Catheter (!50 cm),Turnpike Spiral Catheter (135 cm),Turnpike Spiral Catheter (150cm)
Reg #: 3011137372
·
FEI: 3005747797
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Teleflex Medical LLC
- Registration Number
- 3011137372
- FEI Number
- 3005747797
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3015 Carrington Mill Blvd
- City
- Morrisville
- State
- NC
- ZIP
- 27560
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191560
Owner / Operator
- Firm Name
- Teleflex
- Operator Number
- 9062981
- Address
- 3015 Carrington Mill Blvd.
- City
- Morrisville
- State
- NC
- Postal Code
- 27560
- Country
- US
- Correspondent
- Divya Raman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2021-11-09 |
Proprietary Names
Turnpike Catheter (135 cm),Turnpike Catheter (!50 cm),Turnpike Spiral Catheter (135 cm),Turnpike Spiral Catheter (150cm)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility