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510(k) K242776

LimFlow V-Ceiver by LimFlow, Inc. — Product Code MMX

K242776 is an FDA 510(k) premarket notification submitted by LimFlow, Inc. for the device "LimFlow V-Ceiver". The FDA issued a decision of Substantially Equivalent on February 14, 2025. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. LimFlow, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2025
Date Received
September 13, 2024
Clearance Type
Special
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 by LimFlow, Inc.

  • K260188 — LimFlow Vector (March 18, 2026)
  • K251376 — LimFlow ARC (May 31, 2025)
  • K221902 — LimFlow Vector (December 21, 2022)
  • K221541 — LimFlow ARC (August 31, 2022)
  • K222083 — LimFlow V-Ceiver (August 9, 2022)

Other clearances for product code MMX

  • 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)
  • K212988 — ONO Retrieval Device (May 23, 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