Cleared Special

Amplatz Goose Neck Snare Kit

K241259 · Medtronic, Inc. · Cardiovascular
Jun 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K241259 is an FDA 510(k) clearance for the Amplatz Goose Neck Snare Kit, a Device, Percutaneous Retrieval (Class II — Special Controls, product code MMX), submitted by Medtronic, Inc. (Minneapolis,, US). The FDA issued a Cleared decision on June 3, 2024, 28 days after receiving the submission on May 6, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K241259 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2024
Decision Date June 03, 2024
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MMX — Device, Percutaneous Retrieval
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5150

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