FDA.report

510(k) K251015

Device
APRO 45 Catheter and Alembic Aspiration Tubing
Applicant
Alembic, LLC
510(k) number
K251015
Product code
NRY
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-30
Date received
2025-04-02
Regulation
870.1250
Classification name
Catheter, Thrombus Retriever
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Stina Almaleh
Address
627 National Ave. Mountain View CA US 94043 94043

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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