STEALTH DILATION CATHETER SYSTEM/MODIFICATION— 510(k) K904287

Substantially Equivalent

Target Therapeutics

FDA 510(k) clearance K904287 for STEALTH DILATION CATHETER SYSTEM/MODIFICATION, Substantially Equivalent on 1991-01-16. Applicant: Target Therapeutics.

Clearance details

Applicant: Target Therapeutics
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 1990-09-14
Decision date: 1991-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.