INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES— 510(k) K862739

Substantially Equivalent

Intervascular, Inc.

FDA 510(k) clearance K862739 for INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES, Substantially Equivalent on 1986-08-21. Applicant: Intervascular, Inc..

Clearance details

Applicant
Intervascular, Inc.
Product code
Code DSY
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Clearwater, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DSY

product code DSY
Death
29
Injury
694
Total
723

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.