Cleared Special

K242776 - LimFlow V-Ceiver

K242776 is an FDA 510(k) clearance for LimFlow V-Ceiver, manufactured by LimFlow, Inc.. The device is a Class 2 Cardiovascular device with product code MMX cleared through the Special 510(k) pathway after a 154-day FDA review.

K242776 · LimFlow, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
154d
Days
Class 2
Risk

K242776 is an FDA 510(k) clearance for the LimFlow V-Ceiver. Classified as Device, Percutaneous Retrieval (product code MMX), Class II - Special Controls.

Submitted by LimFlow, Inc. (Irvine, US). The FDA issued a Cleared decision on February 14, 2025 after a review of 154 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K242776

510(k) Number K242776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Modification to existing cleared device.

MMX Device Classification - Class 2, Special Controls

Product Code MMX Device, Percutaneous Retrieval
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MMX Device, Percutaneous Retrieval

All 31
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K242776.
Amplatz Goose Neck Snare Kit
K241259 · Medtronic, Inc. · Jun 2024
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
K232443 · Argon Medical Devices, Inc. · Sep 2023
Gunther Tulip Vena Cava Filter Retrieval Set
K222254 · Cook Incorporated · May 2023
LimFlow V-Ceiver
K222083 · LimFlow, Inc. · Aug 2022
ONO Retrieval Device
K212988 · Onocor Vascular, LLC · May 2022
Aveir Retrieval Catheter
K213494 · Abbott Medical · Apr 2022
K242776 · LimFlow V-Ceiver
Download PDF FDA Summary LimFlow, Inc.