FDA Registration
Active
🇺🇸 United States
ALEMBIC LLC
Reg #: 3014211783
·
FEI: 3014211783
·
Expires 2026
Products
4
Proprietary Names
9
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- ALEMBIC LLC
- Registration Number
- 3014211783
- FEI Number
- 3014211783
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 627 National Ave.
- City
- Mountain View
- State
- CA
- ZIP
- 94043
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243287
Owner / Operator
- Firm Name
- Alembic LLC
- Operator Number
- 10056521
- Address
- 627 National Ave.
- City
- Mountain View
- State
- CA
- Postal Code
- 94043
- Country
- US
- Correspondent
- Lisa Yen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2025-02-26 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2018-07-17 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2018-07-17 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2026-03-23 |
Proprietary Names
APRO 70 Swift Catheter
APRO 55 Swift Catheter
APRO 70 Catheter
Alembic Aspiration Tubing
APRO 45 Intermediate Catheter
APRO 55 Catheter and Alembic Aspiration Tubing
APRO 55 Intermediate Catheter
APRO 55 Catheter
APRO 45 Swift Catheter
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)