AVALON ELITE VASCULAR ACCESS KIT— 510(k) K081940

Name: FDA 510(k) clearance K081940
Creator: U.S. Food and Drug Administration
Published: 2008-11-18

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. Device class: 2.

Clearance details

Applicant: Avalon Laboratories, LLC
Product code: Code DRE
Device class: Class 2
Regulation: 21 CFR 870.1310
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 ↗

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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 →

Recalls naming K081940

K-number listed on FDA's recall record

Z-1603-2020 — Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039Class II·Terminated·Maquet Cardiovascular Us Sales, Llc·20200220

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081940.

Data sourced from openFDA. This site is unofficial and independent of the FDA.