Cleared Traditional

DIGNITY POWER INJECTABLE TITANIUM PORT

K120281 · Medical Components, Inc. · General Hospital
Sep 2012
Decision
230d
Days
Class 2
Risk

About This 510(k) Submission

K120281 is an FDA 510(k) clearance for the DIGNITY POWER INJECTABLE 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 September 17, 2012, 230 days after receiving the submission on January 31, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K120281 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2012
Decision Date September 17, 2012
Days to Decision 230 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

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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