FDA 510(k)

Provisio SLT IVUS System

K-Number: K233948 · 2024-04-23

Decision Date2024-04-23

Product CodeOBJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Provisio SLT IVUS System is a medical device manufactured by Provisio Medical, Inc.. It received FDA 510(k) clearance on 2024-04-23 under approval number K233948. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Provisio SLT IVUS System?

Provisio SLT IVUS System is a medical device that received FDA 510(k) clearance on 2024-04-23. It is manufactured by Provisio Medical, Inc.. The 510(k) number is K233948.

When was Provisio SLT IVUS System approved by the FDA?

Provisio SLT IVUS System received FDA 510(k) clearance on 2024-04-23, under approval number K233948.

What company makes Provisio SLT IVUS System?

Provisio SLT IVUS System is manufactured by Provisio Medical, Inc..

What is the FDA product code for Provisio SLT IVUS System?

The FDA product code for Provisio SLT IVUS System is OBJ.

Related Devices (Code: OBJ)

K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation K160514OptiCross 18, 30 MHz Peripheral Imaging CatheterBoston Scientific Corporation K161125OptiCross X, 40 MHz Coronary Imaging CatheterBoston Scientific Corporation K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)Boston Scientific Corporation K173618ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc. K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)Boston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.