Medical Device Manufacturer · US , Mountain View , CA

Alembic, LLC - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2023

Recent clearances: APRO 45 Catheter, APRO 45 Catheter and Alembic Aspiration Tubing, APRO 55 Intermediate Catheter

10
Total
10
Cleared
0
Denied

FDA 510(k) Regulatory Record - Alembic, LLC Neurology ✕

10 devices
1-10 of 10
Cleared May 01, 2025
APRO 45 Catheter
K251014 · DQY
Neurology · 29d
Cleared Apr 30, 2025
APRO 45 Catheter and Alembic Aspiration Tubing
K251015 · NRY
Neurology · 28d
Cleared Apr 29, 2025
APRO 55 Intermediate Catheter
K250962 · DQY
Neurology · 29d
Cleared Apr 28, 2025
APRO 55 Swift Catheter and Alembic Aspiration Tubing
K250958 · NRY
Neurology · 28d
Cleared Feb 24, 2025
APRO 70 Swift Catheter and Alembic Aspiration Tubing
K243287 · NRY
Neurology · 129d
Cleared Jan 14, 2025
APRO 70 Swift Catheter
K243297 · QJP
Neurology · 88d
Cleared Mar 15, 2024
APRO 55 Catheter
K234115 · DQY
Neurology · 79d
Cleared Feb 29, 2024
APRO 55 Catheter and Alembic Aspiration Tubing
K232971 · NRY
Neurology · 161d
Cleared Apr 10, 2023
APRO 70 Catheter and Alembic Aspiration Tubing
K230695 · NRY
Neurology · 28d
Cleared Feb 17, 2023
APRO 70 Catheter and Alembic Aspiration Tubing
K223545 · NRY
Neurology · 84d
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