Chrysalis Intelligence · Product Codes · OBJ

OBJ · Catheter, Ultrasound, Intravascular

Cardiovascular · 26 clearances · 15 unique sponsors

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Device class
Class II
Regulation 870.1200
Total clearances
26
2020-03-20 → 2026-07-24
Last 12 months
5
Unique sponsors
15
Definition

What is Catheter, Ultrasound, Intravascular

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Classification details
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.1200
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Boston Scientific Corporation 4 1 2026-04-08
Biosense Webster, Inc. 3 0 2024-06-28
Siemens Medical Solutions USA, Inc. 3 0 2023-10-28
Philips Image Guided Therapy Corporation 3 0 2025-05-09
Luma Vision Limited 2 1 2026-07-24
ABBOTT MEDICAL 2 0 2025-05-23
Acist Medical Systems, Inc. 1 0 2020-03-20
Nuvera Medical, Inc. 1 0 2021-03-05
Conavi Medical, Inc. 1 1 2026-04-17
Jiangsu Tingsn Technology Co., Ltd. 1 0 2025-07-19
Northeast Scientific, Inc. 1 0 2020-06-22
Provisio Medical, Inc. 1 0 2024-04-23
Volcano Corporation (Dba Philips Image Guided Therapy Device 1 1 2025-10-28
Irvine Biomedical, A St. Jude Medical Company 1 0 2022-12-07
Yorlabs, Inc. 1 1 2025-10-22
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
93505 CPT — High Intracardiac ultrasound including probe manipulation; standard for intravascular ultrasound catheter
37252 CPT — Medium Intravascular ultrasound during diagnostic angiography; may apply depending on context
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-24 K261849 Luma Vision Limited VERAFEYE Imaging Catheter (VF-VIC-002)
2026-04-17 K252945 Conavi Medical, Inc. Novasight Hybrid System
2026-04-08 K260816 Boston Scientific 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)
2025-10-28 K253399 Volcano Corporation (Dba Philips Image Guided Therapy Device Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter
2025-10-22 K250955 Yorlabs, Inc. XC11 ICE System, USA
2025-07-19 K250913 Jiangsu Tingsn Technology Co., Ltd. TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
2025-05-23 K251211 ABBOTT MEDICAL 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™
2025-05-20 K251231 ABBOTT MEDICAL ViewFlex™ X ICE Catheter, Sensor Enabled™
2025-05-09 K251103 Philips Image Guided Therapy Corporation VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)
2025-03-24 K242893 Luma Vision Limited VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System
2024-06-28 K241540 Biosense Webster, Inc. NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter
2024-06-12 K240050 Biosense Webster, Inc. SOUNDSTAR™ CRYSTAL Ultrasound Catheter
2024-04-23 K233948 Provisio Medical, Inc. Provisio™ SLT IVUS™ System
2023-10-28 K233270 Siemens Medical Solutions USA, Inc. AcuNav Crystal Ultrasound Catheter
2023-05-18 K230453 Boston Scientific Corporation OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter
2023-02-16 K223766 Biosense Webster, Inc. NUVISION™ NAV Ultrasound Catheter
2022-12-07 K223077 Irvine Biomedical, A St. Jude Medical Company ViewFlex Xtra ICE Catheter
2022-09-23 K222568 Boston Scientific Corporation OptiCross™ 18 Peripheral Imaging Catheter
2022-01-14 K213593 Boston Scientific Corporation OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
2021-10-15 K212959 Siemens Medical Solutions USA, Inc. ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
2021-03-05 K201775 Nuvera Medical, Inc. NuVision ICE Catheter
2021-01-19 K203726 Siemens Medical Solutions USA, Inc. ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
2020-09-02 K200812 Philips Image Guided Therapy Corporation VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter
2020-06-22 K200195 Northeast Scientific, Inc. NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
2020-05-22 K200410 Philips Image Guided Therapy Corporation Reconnaissance PV .018 OTW Digital IVUS Catheter
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence