LimFlow V-Ceiver

FDA 510(k) K242776 · LimFlow, Inc.

Substantially Equivalent

510(k) numberK242776

Submission

Device name
LimFlow V-Ceiver
Applicant
LimFlow, Inc.
Irvine, CA, US
Received
September 13, 2024
Decision date
February 14, 2025
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MMX – Device, Percutaneous Retrieval
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5150
Specialty
Cardiovascular

Other 510(k)s with product code MMX

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K241259Amplatz Goose Neck Snare KitMMX · Special Medtronic, Inc.06/03/2024SE
K232443Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitMMX · Special Argon Medical Devices, Inc.09/07/2023SE
K222254Gunther Tulip Vena Cava Filter Retrieval SetMMX · Traditional Cook Incorporated05/16/2023SE
K222083LimFlow V-CeiverMMX · Traditional LimFlow, Inc.08/09/2022SE
K212988ONO Retrieval DeviceMMX · Traditional Onocor Vascular, LLC05/23/2022SE
K213494Aveir Retrieval CatheterMMX · Traditional Abbott Medical04/01/2022SE
K200963Halo Single-Loop Microsnare KitMMX · Traditional Argon Medical Devices, Inc.01/05/2021SE
K200268Halo™ Single-Loop Snare KitMMX · Traditional Argon Medical Devices, Inc.06/03/2020SE
K193507Merit ONE Snare SystemMMX · Special Merit Medical Systems, Inc.01/17/2020SE
K191758Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitMMX · Traditional Argon Medical Devices, Inc.12/17/2019SE

More from Argon Medical Devices, Inc.

510(k)DeviceDecision
K260188LimFlow VectorMGZ · Special 03/18/2026SE
K251376LimFlow ARCPDU · Special 05/31/2025SE
K221902LimFlow VectorMGZ · Traditional 12/21/2022SE
K221541LimFlow ARCPDU · Traditional 08/31/2022SE
K222083LimFlow V-CeiverMMX · Traditional 08/09/2022SE

Questions and answers

When was LimFlow V-Ceiver cleared by the FDA?

LimFlow V-Ceiver (K242776) received a 510(k) decision of Substantially Equivalent on February 14, 2025, 154 days after the submission was received.

What is the product code of K242776?

The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.