FILAO NC RX PTCA DILATATION CATHETER— 510(k) K141933

Substantially Equivalent

Natec Medical , Ltd.

FDA 510(k) clearance K141933 for FILAO NC RX PTCA DILATATION CATHETER, Substantially Equivalent on 2015-06-28. Applicant: Natec Medical , Ltd..

Clearance details

Applicant: Natec Medical , Ltd.
Product code: Code LOX
Advisory panel: Cardiovascular
Date received: 2014-07-16
Decision date: 2015-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LOX

product code LOX

Death: 190
Injury: 1,498
Malfunction: 9,670
Total: 11,358

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.