Cleared Special

MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.

K130725 · Covidien Lp, Formerly Registered AS Kendall · General Hospital

Apr 2013

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K130725 is an FDA 510(k) clearance for the MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR., a Catheter, Umbilical Artery (Class II — Special Controls, product code FOS), submitted by Covidien Lp, Formerly Registered AS Kendall (Mansfield, US). The FDA issued a Cleared decision on April 17, 2013, 30 days after receiving the submission on March 18, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K130725 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2013
Decision Date	April 17, 2013
Days to Decision	30 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF