Cleared Special

Riptide? Aspiration Pump; Riptide? Collection Canister with Intermediate Tubing

K243418 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · General & Plastic Surgery
Dec 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K243418 is an FDA 510(k) clearance for the Riptide? Aspiration Pump; Riptide? Collection Canister with Intermediate Tubing, a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II — Special Controls, product code JCX), submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Lrvine, US). The FDA issued a Cleared decision on December 2, 2024, 28 days after receiving the submission on November 4, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K243418 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 2024
Decision Date December 02, 2024
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code JCX — Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

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