AVALON ELITE VASCULAR ACCESS KIT— 510(k) K081940

Substantially Equivalent

Avalon Laboratories, LLC

FDA 510(k) clearance K081940 for AVALON ELITE VASCULAR ACCESS KIT, Substantially Equivalent on 2008-11-18. Applicant: Avalon Laboratories, LLC.

Clearance details

Applicant: Avalon Laboratories, LLC
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2008-07-08
Decision date: 2008-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Dominguez, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.