NMI FC— 510(k) K091634

Substantially Equivalent

Navilyst Medical, Inc.

FDA 510(k) clearance K091634 for NMI FC, Substantially Equivalent on 2010-03-01. Applicant: Navilyst Medical, Inc..

Clearance details

Applicant: Navilyst Medical, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 2009-06-04
Decision date: 2010-03-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.