510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130639Substantially Equivalent

Elite-I (Bi) Dual Lumen Catheter; Elite-I (Ra) Dual Lumen Catheter; Elite-I (Bix)dual Lumen Catheter

MAQUET CARDIOPULMONARY GmbH, Rastatt De-Bw, DE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130639 is the FDA 510(k) clearance record for ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER, a class II device, cleared for Maquet Cardiopulmonary, AG on under FDA product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass). FDA records list 44 510(k) clearances for Maquet Cardiopulmonary, AG, from to . As of , FDA records show no recalls naming K130639.

Clearance record

Decision date
Received
(66 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
Maquet Cardiopulmonary, AG Kehler Strasse 31, Rastatt De-Bw, DE
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