510(k) K241259

Amplatz Goose Neck Snare Kit by Medtronic, Inc. — Product Code MMX

K241259 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Amplatz Goose Neck Snare Kit". The FDA issued a decision of Substantially Equivalent on June 3, 2024. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. Medtronic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2024
Date Received
May 6, 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