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510(k) K234115

APRO 55 Catheter by Alembic, LLC — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2024
Date Received
December 27, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Alembic, LLC

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  • K250958 — APRO 55 Swift Catheter and Alembic Aspiration Tubing (April 28, 2025)
  • K243287 — APRO 70 Swift Catheter and Alembic Aspiration Tubing (February 24, 2025)
  • K243297 — APRO 70 Swift Catheter (January 14, 2025)
  • K232971 — APRO 55 Catheter and Alembic Aspiration Tubing (February 29, 2024)
  • K230695 — APRO 70 Catheter and Alembic Aspiration Tubing (April 10, 2023)
  • K223545 — APRO 70 Catheter and Alembic Aspiration Tubing (February 17, 2023)

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