Amplatz Goose Neck Snare Kit— 510(k) K241259

Name: FDA 510(k) clearance K241259
Creator: U.S. Food and Drug Administration
Published: 2024-06-03

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K241259 for Amplatz Goose Neck Snare Kit, Substantially Equivalent on 2024-06-03. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code MMX
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2024-05-06
Decision date: 2024-06-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MMX

view all

K242776 — LimFlow V-Ceiver2025-02-14
K232443 — Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit2023-09-07
K222254 — Gunther Tulip Vena Cava Filter Retrieval Set2023-05-16
K222083 — LimFlow V-Ceiver2022-08-09
K212988 — ONO Retrieval Device2022-05-23

More clearances from Medtronic, Inc.

view all

K262735 — LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)2026-08-28
K262005 — Affera Integrated Mapping System2026-08-21
K261335 — VitalFlow Set with Balance Biosurface2026-07-31
K261866 — Concerto Versa Detachable Coil2026-06-24
K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23

Adverse events under product code MMX

product code MMX

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.