Provisio SLT IVUS System
FDA 510(k) K233948 · Provisio Medical, Inc.
510(k) numberK233948
Submission
- Device name
- Provisio SLT IVUS System
- Applicant
- Provisio Medical, Inc.
San Diego, CA, US - Received
- December 14, 2023
- Decision date
- April 23, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Other 510(k)s with product code OBJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261696 | ACUNAV Luxera 4D ICE CatheterOBJ · Special | Siemens Medical Solutions USA, Inc. | 09/10/2026SE |
| K261849 | VERAFEYE Imaging Catheter (VF-VIC-002)OBJ · Special | Luma Vision Limited | 07/24/2026SE |
| K252945 | Novasight Hybrid SystemOBJ · Traditional | Conavi Medical, Inc. | 04/17/2026SE |
| K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter…OBJ · Special | Boston Scientific | 04/08/2026SE |
| K253399 | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterOBJ · Special | Volcano Corporation (Dba Philips Image Guided… | 10/28/2025SE |
| K250955 | XC11 ICE System, USAOBJ · Traditional | Yorlabs, Inc. | 10/22/2025SE |
| K250913 | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemOBJ · Traditional | Jiangsu Tingsn Technology Co., Ltd. | 07/19/2025SE |
| K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid…OBJ · Special | Abbott Medical | 05/23/2025SE |
| K251231 | ViewFlex X ICE Catheter, Sensor EnabledOBJ · Special | Abbott Medical | 05/20/2025SE |
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac…OBJ · Special | Philips Image Guided Therapy Corporation | 05/09/2025SE |
Questions and answers
When was Provisio SLT IVUS System cleared by the FDA?
Provisio SLT IVUS System (K233948) received a 510(k) decision of Substantially Equivalent on April 23, 2024, 131 days after the submission was received.
What is the product code of K233948?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.