510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895352Substantially Equivalent

Kendall Infant Ecmo Venovenous Catheter-Dual Lumen

Kendall Healthcare Products Co. Div.Of Tyco Health, Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895352 is the FDA 510(k) clearance record for KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN, a class II device, cleared for Kendall Healthcare Products Co. Div.Of Tyco Health on under FDA product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass). FDA records list 66 510(k) clearances for Kendall Healthcare Products Co. Div.Of Tyco Health, from to . As of , FDA records show no recalls naming K895352.

Clearance record

Decision date
Received
(89 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
Kendall Healthcare Products Co. Div.Of Tyco Health 15 Hampshire St., Mansfield MA
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