FDA Registration
Active
🇺🇸 United States
R2P Destination Slender Guiding Sheath
Reg #: 1118880
·
FEI: 1118880
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TERUMO MEDICAL CORP.
- Registration Number
- 1118880
- FEI Number
- 1118880
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 950 ELKTON BLVD.
- City
- ELKTON
- State
- MD
- ZIP
- 21921
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193125
Owner / Operator
- Firm Name
- TERUMO MEDICAL CORP.
- Operator Number
- 9003933
- Address
- 265 Davidson Avenue, Ste. 320
- City
- Somerset
- State
- NJ
- Postal Code
- 08873
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2020-01-20 |
Proprietary Names
R2P Destination Slender Guiding Sheath
Establishment Types
Manufacture Medical Device