Cleared Special

NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS

K112713 · Norfolk Medical Products, Inc. · General Hospital
Oct 2011
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K112713 is an FDA 510(k) clearance for the NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by Norfolk Medical Products, Inc. (Skokie, US). The FDA issued a Cleared decision on October 27, 2011, 38 days after receiving the submission on September 19, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K112713 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2011
Decision Date October 27, 2011
Days to Decision 38 days
Submission Type Special
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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