510(k) K241828
- Device
- Affera Integrated Mapping System; Impedance Localization Patch Kit
- Applicant
- Medtronic, Inc.
- 510(k) number
- K241828
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-01
- Date received
- 2024-06-24
- Regulation
- 870.1425
- Classification name
- Computer, Diagnostic, Programmable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Matthew Lobeck
- Address
- 8200 Coral Sea St. N.E Mounds View MN US 55112 55112
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 20763000980096 | NA | MEDTRONIC, INC. | 2025-08-15 |
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| K260212 | EnSite X EP System | ABBOTT MEDICAL | 2026-04-20 |
| K253861 | ACORYS MAPPING SYSTEM | Corify Care S.L | 2026-04-13 |
| K253473 | Synchrony | Stereotaxis, Inc. | 2026-04-01 |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026-02-24 |
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| K251218 | SafeBeat Rx App | SafeBeat Rx, Inc. | 2026-02-06 |
| K252164 | NorthStar Mapping System | Imricor Medical Systems | 2026-01-28 |
| K254085 | CARTO 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. | 2026-01-18 |
| K253733 | STAR Apollo Mapping System | Rhythm AI, Ltd. | 2025-12-19 |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025-12-18 |
| K253141 | DeepRhythmAI | Medicalgorithmics S.A. | 2025-12-11 |
| K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | 2025-12-04 |
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