OBJ — Catheter, Ultrasound, Intravascular Class II
Classification Details
- Product Code
- OBJ
- Device Class
- Class II
- Regulation Number
- 870.1200
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253399 | volcano corporation (dba philips image guided therapy device | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Cathe | October 28, 2025 |
| K250955 | yorlabs | XC11 ICE System, USA | October 22, 2025 |
| K250913 | jiangsu tingsn technology co | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System | July 19, 2025 |
| K251211 | abbott medical | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD | May 23, 2025 |
| K251231 | abbott medical | ViewFlex X ICE Catheter, Sensor Enabled | May 20, 2025 |
| K251103 | philips image guided therapy corporation | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intrac | May 9, 2025 |
| K242893 | luma vision limited | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | March 24, 2025 |
| K241540 | biosense webster | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter | June 28, 2024 |
| K240050 | biosense webster | SOUNDSTAR CRYSTAL Ultrasound Catheter | June 12, 2024 |
| K233948 | provisio medical | Provisio SLT IVUS System | April 23, 2024 |
| K233270 | siemens medical solutions usa | AcuNav Crystal Ultrasound Catheter | October 28, 2023 |
| K230453 | boston scientific corporation | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Cath | May 18, 2023 |
| K223766 | biosense webster | NUVISION NAV Ultrasound Catheter | February 16, 2023 |
| K223077 | irvine biomedical, a st. jude medical | ViewFlex Xtra ICE Catheter | December 7, 2022 |
| K222568 | boston scientific corporation | OptiCross 18 Peripheral Imaging Catheter | September 23, 2022 |
| K213593 | boston scientific corporation | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD | January 14, 2022 |
| K212959 | siemens medical solutions usa | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | October 15, 2021 |
| K201775 | nuvera medical | NuVision ICE Catheter | March 5, 2021 |
| K203726 | siemens medical solutions usa | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | January 19, 2021 |
| K200812 | philips image guided therapy corporation | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Cathet | September 2, 2020 |