510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081820Substantially Equivalent

Avalon Elite Bi-Caval Dual Lumen Catheter, 13Fr, 16Fr, 19Fr, 20Fr, 23Fr, 27Fr, 31Fr

Avalon Laboratories, LLC, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081820 is the FDA 510(k) clearance record for AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR, a class II device, cleared for Avalon Laboratories, LLC on under FDA product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass). FDA records list 3 510(k) clearances for Avalon Laboratories, LLC, from to . As of , FDA records show no recalls naming K081820.

Clearance record

Decision date
Received
(101 days to decision)
Product code
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Regulation
21 CFR 870.4210
Device class
Class II
Review panel
Cardiovascular
Applicant
Avalon Laboratories, LLC 5200 Crystal Water Dr., Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DWF

Trailing 12 months
6 clearances under product code DWF in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DWF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20262
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260