DeviceClearance

Provisio SLT IVUS System— 510(k) K233948

Substantially Equivalent

Provisio Medical, Inc.

FDA 510(k) clearance K233948 for Provisio SLT IVUS System, Substantially Equivalent on 2024-04-23. Applicant: Provisio Medical, Inc.. Device class: 2.

Clearance details

Applicant
Provisio Medical, Inc.
Product code
Code OBJ
Device class
Class 2
Regulation
21 CFR 870.1200
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code OBJ

view all

Adverse events under product code OBJ

product code OBJ
Death
38
Injury
634
Malfunction
3,453
Total
4,125

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.