Cleared Traditional

ONO Retrieval Device

K212988 · Onocor Vascular, LLC · Cardiovascular

May 2022

Decision

245d

Days

Class 2

Risk

About This 510(k) Submission

K212988 is an FDA 510(k) clearance for the ONO Retrieval Device, a Device, Percutaneous Retrieval (Class II — Special Controls, product code MMX), submitted by Onocor Vascular, LLC (West Chester, US). The FDA issued a Cleared decision on May 23, 2022, 245 days after receiving the submission on September 20, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K212988 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2021
Decision Date	May 23, 2022
Days to Decision	245 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF