Cleared Traditional

LimFlow V-Ceiver

K222083 · LimFlow, Inc. · Cardiovascular

Aug 2022

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K222083 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. (San Jose, US). The FDA issued a Cleared decision on August 9, 2022, 25 days after receiving the submission on July 15, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K222083 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2022
Decision Date	August 09, 2022
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF