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510(k) K233329

Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set by Route 92 Medical, Inc. — Product Code NRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2024
Date Received
September 29, 2023
Clearance Type
Special
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 Route 92 Medical, Inc.

  • K243601 — Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (May 19, 2025)
  • K240529 — 8F Modified Sheath System (October 2, 2024)
  • K231583 — Route 92 Medical Full Length 054 Access System (August 15, 2023)
  • K223530 — Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set (April 11, 2023)
  • K222743 — Route 92 Medical Full Length 070 Access System (October 4, 2022)
  • K210635 — Route 92 Medical Full Length 088 Access System (July 27, 2021)
  • K203043 — Route 92 Medical 070 Access System (November 11, 2020)
  • K201518 — Route 92 Medical 088 Access System (August 14, 2020)
  • K200121 — Route 92 Medical 088 Access System, 110 cm (April 18, 2020)
  • K191717 — Route 92 Medical Sheath System (January 13, 2020)

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  • 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)