AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR— 510(k) K081820

Substantially Equivalent

Avalon Laboratories, LLC

FDA 510(k) clearance K081820 for AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR, Substantially Equivalent on 2008-10-06. Applicant: Avalon Laboratories, LLC.

Clearance details

Applicant: Avalon Laboratories, LLC
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2008-06-27
Decision date: 2008-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.