ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0— 510(k) K030062

Substantially Equivalent

Avantec Vascular Corp.

FDA 510(k) clearance K030062 for ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0, Substantially Equivalent on 2003-04-03. Applicant: Avantec Vascular Corp..

Clearance details

Applicant: Avantec Vascular Corp.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2003-01-07
Decision date: 2003-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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.