Cleared Traditional

5F DIGNITY CT TITANIUM PORT

K130923 · Medical Components, Inc. · General Hospital
Jul 2013
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K130923 is an FDA 510(k) clearance for the 5F DIGNITY CT TITANIUM PORT, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on July 31, 2013, 119 days after receiving the submission on April 3, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K130923 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2013
Decision Date July 31, 2013
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5965

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