Atlas FDA

ViewFlex™ X ICE Catheter, Sensor Enabled™

FDA 510(k) clearance K251231 · decided 2025-05-20

Clearance details

K-number
K251231
Device name
ViewFlex™ X ICE Catheter, Sensor Enabled™
Applicant
ABBOTT MEDICAL
Decision
Substantially Equivalent
Date received
2025-04-22
Decision date
2025-05-20
Days to decision
28 days
Clearance type
Special
Product code
OBJ
Device class
2
Regulation number
870.1200
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Irvine, CA, 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
VERAFEYE Imaging Catheter (VF-VIC-002) (K261849)Luma Vision Limited2026-07-24
Novasight Hybrid System (K252945)Conavi Medical, Inc.2026-04-17
OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) (K260816)Boston Scientific2026-04-08
Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter (K253399)Volcano Corporation (Dba Philips Image Guided Therapy Device2025-10-28
XC11 ICE System, USA (K250955)Yorlabs, Inc.2025-10-22
TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System (K250913)Jiangsu Tingsn Technology Co., Ltd.2025-07-19
ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ (K251211)ABBOTT MEDICAL2025-05-23
VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) (K251103)Philips Image Guided Therapy Corporation2025-05-09
VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (K242893)Luma Vision Limited2025-03-24
NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (K241540)Biosense Webster, Inc.2024-06-28
SOUNDSTAR™ CRYSTAL Ultrasound Catheter (K240050)Biosense Webster, Inc.2024-06-12
Provisio™ SLT IVUS™ System (K233948)Provisio Medical, Inc.2024-04-23

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Proclaim Dorsal Root Ganglion (DRG) System (P150004/S092)ABBOTT MEDICAL2025-12-23
Proclaim™ Spinal Cord Stimulation (SCS) System (P010032/S246)ABBOTT MEDICAL2025-12-23
Infinity™ Deep Brain Stimulation (DBS) System (P140009/S127)ABBOTT MEDICAL2025-12-23
Amplatzer™ Amulet™ Left Atrial Appendage Occluder (P200049/S014)ABBOTT MEDICAL2025-12-23
Volt™ PFA System (P250022)ABBOTT MEDICAL2025-12-19
HeartMate II™ Left Ventricular Assist System (P060040/S122)ABBOTT MEDICAL2025-12-17
HeartMate 3™ Left Ventricular Assist System (P160054/S116)ABBOTT MEDICAL2025-12-17
Durata Leads; Optisure Leads (P950022/S151)ABBOTT MEDICAL2025-12-09