Alembic LLC
Mountain View, CA, US
ALEMBIC LLC appears in FDA device records in Mountain View, CA. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Alembic LLC between 2023 and 2026. The busiest year on record is 2025, with 6. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 6 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262392 | APRO 35 Swift Catheter | DQY | Substantially Equivalent | |
| K262391 | APRO 35 Swift Catheter and Alembic Aspiration Tubing | NRY | Substantially Equivalent | |
| K251014 | APRO 45 Catheter | DQY | Substantially Equivalent | |
| K251015 | APRO 45 Catheter and Alembic Aspiration Tubing | NRY | Substantially Equivalent | |
| K250962 | APRO 55 Intermediate Catheter | DQY | Substantially Equivalent | |
| K250958 | APRO 55 Swift Catheter and Alembic Aspiration Tubing | NRY | Substantially Equivalent | |
| K243287 | APRO 70 Swift Catheter and Alembic Aspiration Tubing | NRY | Substantially Equivalent | |
| K243297 | APRO 70 Swift Catheter | QJP | Substantially Equivalent | |
| K234115 | APRO 55 Catheter | DQY | Substantially Equivalent | |
| K232971 | APRO 55 Catheter and Alembic Aspiration Tubing | NRY | Substantially Equivalent | |
| K230695 | APRO 70 Catheter and Alembic Aspiration Tubing | NRY | Substantially Equivalent | |
| K223545 | APRO 70 Catheter and Alembic Aspiration Tubing | NRY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014211783 | 3014211783 | ALEMBIC LLC | 627 National Ave., Mountain View, CA 94043 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain