# K233948: Provisio™ SLT IVUS™ System

- Pathway: 510(k) (Traditional)
- Applicant: Provisio Medical, Inc.
- Decided: Apr 23, 2024 after 131 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K934139 (1995). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200410: Reconnaissance PV .018 OTW Digital IVUS Catheter, Philips Image Guided Therapy Corporation (2020) Summary page 5.
- K092396: Spectranetics Quick Cross Extreme Support Catheters, Spectranetics Corp. (2009) Summary page 5.
- K173860: s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System, Volcano Corporation (2018) Summary page 5.

## Indications for use
The Provisio™ SLT IVUS™ System is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature. The Provisio™ SLT IVUS™ System is designed for use as an adjunct to conventional angiographic procedures to evaluate the vessel lumen and provide dimensional measurements. The SLT IVUS™ Support Crossing Catheter also guides and supports a guidewire during access of the vasculature and provides a conduit for the delivery of saline solutions or radiopaque contrast agents.

Source page: https://510kreport.com/device/K233948
Methodology: https://510kreport.com/methodology