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510(k) K243418

Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — Product Code JCX

K243418 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular for the device "Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing". The FDA issued a decision of Substantially Equivalent on December 2, 2024. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Micro Therapeutics, Inc. d/b/a ev3 Neurovascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2024
Date Received
November 4, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

Other clearances by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

  • K241388 — Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Ri (January 2, 2025)
  • K243080 — Riptide Aspiration System (October 29, 2024)
  • K211990 — Rist 071 Radial Access Guide Catheter (July 27, 2021)
  • K203432 — Axium Detachable Coil; Axium Prime Detachable Coil (July 7, 2021)
  • K203358 — Solitaire X Revascularization Device (March 1, 2021)
  • K202850 — Concerto Versa, Detachable Coil (February 9, 2021)
  • K193576 — Solitaire Platinum Revascularization Device, Solitaire X Revascularization Devic (November 20, 2020)
  • K202318 — Marathon Flow Directed Micro Catheter (September 14, 2020)
  • K201690 — Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire (July 21, 2020)
  • K201689 — Riptide Aspiration System (July 21, 2020)

Other clearances for product code JCX

  • K250964 — Protable Phlegm Suction Unit (JMA D01) (May 11, 2026)
  • K243638 — MV Flow Aspiration Pump (MVFLOWPMP01) (June 13, 2025)
  • K251111 — Cary (May 7, 2025)
  • K233428 — Easycess Aspiration Pump (November 3, 2023)
  • K222552 — 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specime (December 9, 2022)
  • K182950 — Acare Suction Unit (August 23, 2019)
  • K190789 — IntelliCartTM System (April 24, 2019)
  • K190105 — ZOOM Aspiration Pump (February 21, 2019)
  • K180115 — TWBM Pump (July 24, 2018)
  • K181398 — DV-300 Aspirator (July 23, 2018)

FDA data resources