TRIFIT 700— 510(k) K033646

Substantially Equivalent

Healthfirst Corp.

FDA 510(k) clearance K033646 for TRIFIT 700, Substantially Equivalent on 2005-03-01. Applicant: Healthfirst Corp..

Clearance details

Applicant: Healthfirst Corp.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2003-11-20
Decision date: 2005-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albuquerque, NM, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.