FDA Registration
Active
🇺🇸 United States
Angler Steerable, Deflectable Microcatheter
Reg #: 3023167283
·
FEI: 3023167283
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AGILE DEVICES, INC.
- Registration Number
- 3023167283
- FEI Number
- 3023167283
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1087 Beacon Street, Suite 302
- City
- Newton Centre
- State
- MA
- ZIP
- 02459
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211110
Owner / Operator
- Firm Name
- Agile Devices, Inc.
- Operator Number
- 10085522
- Address
- 1087 Beacon Street, Suite 302
- City
- Newton Centre
- State
- MA
- Postal Code
- 02459
- Country
- US
- Correspondent
- Benjamin Merewitz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2022-06-28 |
Proprietary Names
Angler Steerable, Deflectable Microcatheter
Establishment Types
Manufacture Medical Device