Affera Integrated Mapping System
Medtronic, Inc. · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Mounds View
- Advisory committee description
- Cardiovascular
- Address 1
- 8200 Coralsea St. N.E,
- Statement or summary
- Summary
- Product code
- DQK
- Zip code
- 55112
- Applicant
- Medtronic, Inc.
- Decision date
- 2026-08-21
- Decision code
- SESE
- Country code
- US
- Device name
- Affera Integrated Mapping System
- Advisory committee
- CV
- Contact
- Matthew Lobeck
- K number
- K262005
- State
- MN
- Date received
- 2026-06-15
- Review advisory committee
- CV
- Postal code
- 55112
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Computer, Diagnostic, Programmable
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1425
- Device class
- 2
- Registration number
- 3009443693, 1316463, 8022257, 3010288146, 1224919, 8030978, 3005334138, 3017840980, 3004091615, 2029275, 3011353843, 2126666, 3001570235, 3017060084, 9617277, 9610105, 3000279201, 3004415095, 3012154226, 3042175841, 3013679558, 3045498928, 1218950, 3018940143, 1319660, 3031786139, 3033959233, 2134265, 3013596024, 3007029079, 3012027770, 1650907, 3003971136, 2438852, 3008363989, 3022451073, 9616760, 3017401510, 3010089768, 3012179728 +144 more
- FEI number
- 3009443693, 1316463, 3010288146, 3005334138, 3017840980, 3003081151, 3004091615, 3011353843, 2126666, 3001570235, 3017060084, 3002807880, 3000279201, 3004415095, 3012154226, 3003190524, 3013679558, 3042175841, 3045498928, 1000513706, 1218950, 3018940143, 3031786139, 3033959233, 3013596024, 3003248396, 3007029079, 3012027770, 3003971136, 3008363989, 3004099094, 3022451073, 3003757840, 3017401510, 3010089768, 3012179728, 1018233, 3008329188, 3004977335, 3012520654 +144 more