FDA.report

510(k) K230695

Device
APRO 70 Catheter and Alembic Aspiration Tubing
Applicant
Alembic, LLC
510(k) number
K230695
Product code
NRY
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-10
Date received
2023-03-13
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
No

Related Records

Applicant Contact

Contact
Lisa Yen
Address
627 National Ave. Mountain View CA US 94043 94043

FDA Registration Numbers

Source Documents

510(k) summary PDF

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