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510(k) K212988

ONO Retrieval Device by Onocor Vascular, LLC — Product Code MMX

K212988 is an FDA 510(k) premarket notification submitted by Onocor Vascular, LLC for the device "ONO Retrieval Device". The FDA issued a decision of Substantially Equivalent on May 23, 2022. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2022
Date Received
September 20, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Percutaneous Retrieval
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

Other clearances for product code MMX

  • K242776 — LimFlow V-Ceiver (February 14, 2025)
  • K241259 — Amplatz Goose Neck Snare Kit (June 3, 2024)
  • K232443 — Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit (September 7, 2023)
  • K222254 — Gunther Tulip Vena Cava Filter Retrieval Set (May 16, 2023)
  • K222083 — LimFlow V-Ceiver (August 9, 2022)
  • K213494 — Aveir Retrieval Catheter (April 1, 2022)
  • K200963 — Halo Single-Loop Microsnare Kit (January 5, 2021)
  • K200268 — Halo™ Single-Loop Snare Kit (June 3, 2020)
  • K193507 — Merit ONE Snare System (January 17, 2020)
  • K191758 — Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit (December 17, 2019)

FDA data resources