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510(k) K243297

APRO 70 Swift Catheter by Alembic, LLC — Product Code QJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2025
Date Received
October 18, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

To provide vascular access to the neurovasculature for interventional or diagnostic procedures

Other clearances by Alembic, LLC

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  • K251015 — APRO 45 Catheter and Alembic Aspiration Tubing (April 30, 2025)
  • K250962 — APRO 55 Intermediate Catheter (April 29, 2025)
  • K250958 — APRO 55 Swift Catheter and Alembic Aspiration Tubing (April 28, 2025)
  • K243287 — APRO 70 Swift Catheter and Alembic Aspiration Tubing (February 24, 2025)
  • K234115 — APRO 55 Catheter (March 15, 2024)
  • 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)

Other clearances for product code QJP

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  • K252297 — Toro 88 Superbore Catheter (January 16, 2026)
  • K251097 — V-DAC Catheter (January 6, 2026)
  • K251668 — SurfRider 13 Microcatheter (January 5, 2026)
  • K252213 — Bendit17 Microcatheter (December 3, 2025)
  • K251372 — VersaD Delivery Catheter (October 24, 2025)
  • K252569 — Carrier XL Delivery Catheter (October 22, 2025)
  • K250960 — DUO Microcatheter (September 8, 2025)
  • K251240 — Branchor X Balloon Guide Catheter (June 20, 2025)
  • K251560 — FUBUKI XF-R Neurovascular Long Sheath (June 20, 2025)