510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130725Substantially Equivalent

Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5Fr, 3.5Fr, 5 Fr.

Covidien Lp, Formerly Registered AS Kendall, Mansfield MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130725 is the FDA 510(k) clearance record for MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR., a class II device, cleared for Covidien Lp, Formerly Registered AS Kendall on under FDA product code FOS (Catheter, Umbilical Artery). FDA records list 3 510(k) clearances for Covidien Lp, Formerly Registered AS Kendall, from to . As of , FDA records show 3 recalls naming K130725.

Clearance record

Decision date
Received
(30 days to decision)
Product code
FOS Catheter, Umbilical Artery
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Covidien Lp, Formerly Registered AS Kendall 15 Hampshire St., Mansfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FOS

Trailing 12 months

FDA records hold no clearances under product code FOS in the trailing twelve months.

FDA records show no clearances under product code FOS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FOS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260