EBONY PTA .035 PERIPHERAL DILATATION CATHETER— 510(k) K103354

Substantially Equivalent

Natec Medical , Ltd.

FDA 510(k) clearance K103354 for EBONY PTA .035 PERIPHERAL DILATATION CATHETER, Substantially Equivalent on 2011-02-23. Applicant: Natec Medical , Ltd..

Clearance details

Applicant: Natec Medical , Ltd.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2010-11-16
Decision date: 2011-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

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Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.