Cleared Traditional

NORFOLK MEDICAL NORPORT FAMILY OF PORTS

K102385 · Norfolk Medical Products, Inc. · General Hospital
Jan 2011
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K102385 is an FDA 510(k) clearance for the NORFOLK MEDICAL NORPORT 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 January 14, 2011, 144 days after receiving the submission on August 23, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K102385 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2010
Decision Date January 14, 2011
Days to Decision 144 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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