Cleared Special

LimFlow V-Ceiver

K242776 · LimFlow, Inc. · Cardiovascular
Feb 2025
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K242776 is an FDA 510(k) clearance for the LimFlow V-Ceiver, a Device, Percutaneous Retrieval (Class II — Special Controls, product code MMX), submitted by LimFlow, Inc. (Irvine, US). The FDA issued a Cleared decision on February 14, 2025, 154 days after receiving the submission on September 13, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K242776 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2024
Decision Date February 14, 2025
Days to Decision 154 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MMX — Device, Percutaneous Retrieval
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5150

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