Atlas FDA

Sphere-9Dx Diagnostic Catheter (AFR-00009)

FDA 510(k) clearance K233433 · decided 2024-08-07

Clearance details

K-number
K233433
Device name
Sphere-9Dx Diagnostic Catheter (AFR-00009)
Applicant
Medtronic
Decision
Substantially Equivalent
Date received
2023-10-12
Decision date
2024-08-07
Days to decision
300 days
Clearance type
Traditional
Product code
MTD
Device class
2
Regulation number
870.1220
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mounds View, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
OptiMap Catheter - 60mm (OPTI-CATH2-60) (K261012)Cortex, Inc.2026-04-23
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Ablacath™ Mapping Catheter (K223666)Ablacon, Inc.2023-03-17
OPTRELL™ Mapping Catheter with TRUEref™ Technology (K230253)Biosense Webster, Inc.2023-03-02
AcQMap 3D Imaging and Mapping Catheter, Model 900009 (K210766)Acutus Medical, Inc.2022-06-21
OPTRELL Mapping Catheter with TRUEref Technology (K211438)Biosense Webster, Inc.2022-03-18
Reprocessed PentaRay Nav eco High-Density Mapping Catheter (K201806)Sterilmed Inc. (Johnson and Johnson)2021-06-23
AcQMap 3D Imaging and Mapping Catheter (K201341)Acutus Medical, Inc.2020-09-15
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled (K200212)Innovative Health, LLC2020-09-03
Pentaray Nav eco High-Density Mapping Catheter (K201750)Biosense Webster, Inc.2020-08-06

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
HeartWare HVAD System (P100047/S227)Medtronic2025-07-09
HeartWare­™ Ventricular Assist System (HVAD) (P100047/S230)Medtronic2025-06-26
HeartWare™ Ventricular Assist System (HVAD) (P100047/S229)Medtronic2025-06-05
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S228)Medtronic2025-06-04
HeartWare HVAD System (P100047/S226)Medtronic2025-05-05
HeartWare® HVAD System (P100047/S225)Medtronic2025-04-24
HeartWare HVAD System (P100047/S224)Medtronic2025-04-02
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S222)Medtronic2025-03-13