ONO Retrieval Device

FDA 510(k) K212988 · Onocor Vascular, LLC

Substantially Equivalent

510(k) numberK212988

Submission

Device name
ONO Retrieval Device
Applicant
Onocor Vascular, LLC
West Chester, PA, US
Received
September 20, 2021
Decision date
May 23, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 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

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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
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

Questions and answers

When was ONO Retrieval Device cleared by the FDA?

ONO Retrieval Device (K212988) received a 510(k) decision of Substantially Equivalent on May 23, 2022, 245 days after the submission was received.

What is the product code of K212988?

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