Cleared Traditional

LimFlow Vector

K221902 · LimFlow, Inc. · Cardiovascular
Dec 2022
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K221902 is an FDA 510(k) clearance for the LimFlow Vector, a Valvulotome (Class II — Special Controls, product code MGZ), submitted by LimFlow, Inc. (San Jose, US). The FDA issued a Cleared decision on December 21, 2022, 174 days after receiving the submission on June 30, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number K221902 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2022
Decision Date December 21, 2022
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MGZ — Valvulotome
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4885

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