K243892
- 510(k) number
- K243892
- Device name
- Affera Integrated Mapping System
- Applicant
- Medtronic, Inc. MN · US
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2025-01-17
- Date received
- 2024-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243892.pdf
Official FDA record: K243892
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.