FDA Registration
Active
🇺🇸 United States
18G x 5.4cm (2.125 inch) Modified Cournand 2-Part Introducer
Reg #: 1835568
·
FEI: 3001237677
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- RLS Interventional Inc. DBA Inrad
- Registration Number
- 1835568
- FEI Number
- 3001237677
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4375 Donkers Ct SE
- City
- Grand Rapids
- State
- MI
- ZIP
- 49512
- Country
- US
Regulatory Submissions
- 510(k) Number
- K812973
Owner / Operator
- Firm Name
- INRAD
- Operator Number
- 9031756
- Address
- 4375 DONKER COURT S.E., --
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49512
- Country
- US
- Correspondent
- Heidi - Halverson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2007-12-06 |
Proprietary Names
18G x 5.4cm (2.125 inch) Modified Cournand 2-Part Introducer
18G x 5.4cm (2.125 inch) Cournand 2-Part Introducer
Establishment Types
Manufacture Medical Device