FDA 510(k)

ONO Retrieval Device

K-Number: K212988 · 2022-05-23

Decision Date2022-05-23

Product CodeMMX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ONO Retrieval Device is the device name listed in this FDA 510(k) record. The listed applicant is Onocor Vascular, LLC. It received FDA 510(k) clearance on 2022-05-23 under 510(k) number K212988. The device is classified under product code MMX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONO Retrieval Device?

ONO Retrieval Device is a medical device that received FDA 510(k) clearance on 2022-05-23. The listed applicant is Onocor Vascular, LLC. The 510(k) number is K212988.

When did ONO Retrieval Device receive FDA 510(k) clearance?

ONO Retrieval Device received FDA 510(k) clearance on 2022-05-23, under 510(k) number K212988.

Who is the listed applicant for ONO Retrieval Device?

The FDA 510(k) record lists Onocor Vascular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONO Retrieval Device?

The FDA product code for ONO Retrieval Device is MMX.

Related Devices (Code: MMX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242776LimFlow V-CeiverLimFlow, Inc.K241259Amplatz Goose Neck Snare KitMedtronic, Inc.K232443Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc.K222254Gunther Tulip Vena Cava Filter Retrieval SetCook Incorporated K222083LimFlow V-CeiverLimFlow, Inc.K213494Aveir Retrieval CatheterABBOTT MEDICAL

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.