510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K111147Substantially Equivalent

Medline Vessel Cannula

MEDLINE INDUSTRIES, LP - Northfield, Mundelein IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111147 is the FDA 510(k) clearance record for MEDLINE VESSEL CANNULA, a class II device, cleared for Medline Industries, Inc. on under FDA product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K111147.

Clearance record

Decision date
Received
(85 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
Medline Industries, Inc. One Medline Pl., Mundelein IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DWF

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