Cleared Traditional

K233948 - Provisio™ SLT IVUS™ System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233948 · Provisio Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
131d
Days
Class 2
Risk

K233948 is an FDA 510(k) clearance for the Provisio™ SLT IVUS™ System. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Provisio Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on April 23, 2024 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Provisio Medical, Inc. devices

Submission Details

510(k) Number K233948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2023
Decision Date April 23, 2024
Days to Decision 131 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 125d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBJ Catheter, Ultrasound, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Veranex, Inc.
Zane Liu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OBJ Catheter, Ultrasound, Intravascular

All 77
Devices cleared under the same product code (OBJ) and FDA review panel - the closest regulatory comparables to K233948.
Novasight Hybrid System
K252945 · Conavi Medical, Inc. · Apr 2026
OptiCross Coronary Imaging Catheter (H749518110)
K260816 · Boston Scientific · Apr 2026
Visions® PV .014P RX Digital IVUS Catheter
K253399 · Volcano Corporation (Dba Philips Image Guided Therapy Device · Oct 2025
XC11 ICE System, USA
K250955 · Yorlabs, Inc. · Oct 2025
TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
K250913 · Jiangsu Tingsn Technology Co., Ltd. · Jul 2025
ViewFlex™ Xtra ICE Catheter
K251211 · Abbott Medical · May 2025