510(k) K243435
K243435 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Magnetic Localization Patch Kit (AFR-00021)". The FDA issued a decision of Substantially Equivalent on December 5, 2024. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Medtronic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2024
- Date Received
- November 5, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type