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510(k) K251014

APRO 45 Catheter by Alembic, LLC — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2025
Date Received
April 2, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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