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510(k) K243287

APRO 70 Swift Catheter and Alembic Aspiration Tubing by Alembic, LLC — Product Code NRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2025
Date Received
October 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Thrombus Retriever
Device Class
Class II
Regulation Number
870.1250
Review Panel
NE
Submission Type

The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.

Other clearances by Alembic, LLC

  • K251014 — APRO 45 Catheter (May 1, 2025)
  • 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)
  • K243297 — APRO 70 Swift Catheter (January 14, 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 NRY

  • K253062 — Tigertriever 25 Revascularization Device (March 12, 2026)
  • K251357 — Esperance pHLO Aspiration System (January 15, 2026)
  • K251006 — NeVasc Aspiration System (November 10, 2025)
  • K252046 — Zoom System (Zoom 4S Catheter) (October 30, 2025)
  • K251603 — Tigertriever 17 Ultra Revascularization Device (October 6, 2025)
  • K251789 — EMBOTRAP III Revascularization Device (September 25, 2025)
  • K252392 — Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set (August 29, 2025)
  • K251828 — CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set (August 22, 2025)
  • K243948 — Raptor Aspiration Catheter; Balt Aspiration Tubing Set (June 3, 2025)
  • K243047 — Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing (May 28, 2025)