Atlas FDA

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)

FDA 510(k) clearance K233943 · decided 2024-03-08

Clearance details

K-number
K233943
Device name
Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2023-12-14
Decision date
2024-03-08
Days to decision
85 days
Clearance type
Traditional
Product code
DQK
Device class
2
Regulation number
870.1425
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mounds View, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Medtronic

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
CorVista System® with PCWP Add-On (K253576)Analytics For Life, Inc.2026-07-26
EnSite™ X EP System (K262006)Abbott Medical2026-07-15
ScioCardio ECG Analysis Platform (K252978)Synergen Technology Labs, LLC2026-07-09
ILR ECG Analyzer (IM007) (K253463)Implicity, Inc.2026-07-02
NorthStar Mapping System (MAP01 or MAP01-01) (K261119)Imricor Medical Systems, Inc.2026-06-30
OneStim-DUO Cardiac Stimulator (MP5003-4CO) (K253088)Micropace Pty, Ltd.2026-06-12
Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) (K261329)Centerline Biomedical2026-06-10
ZEUS Platform (FG0501US) (K252859)iRhythm Technologies, Inc.2026-05-29
EnSite™ X EP System (K260212)ABBOTT MEDICAL2026-04-20
ACORYS MAPPING SYSTEM (K253861)Corify Care S.L2026-04-13
Synchrony (K253473)Stereotaxis, Inc.2026-04-01
HemoSphere Nano Monitor (HSNANO1) (K253186)Edwards Lifesciences, LLC2026-02-24

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S455)Medtronic, Inc.2025-12-22
Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S527)Medtronic, Inc.2025-12-22
Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S574)Medtronic, Inc.2025-12-19
SynchroMed™ Infusion Systems (P860004/S453)Medtronic, Inc.2025-12-19
Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526)Medtronic, Inc.2025-12-18
Activa™ Deep Brain Stimulation Therapy System (P960009/S514)Medtronic, Inc.2025-12-17
Aurora EV-ICD System (P220012/S061)Medtronic, Inc.2025-12-15
Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™ (P960009/S524)Medtronic, Inc.2025-12-08