Cleared Traditional

DIRECT ANTIBIOTIC INFUSION KIT

K113043 · Summit Medical Products, Inc. · General & Plastic Surgery
Dec 2011
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K113043 is an FDA 510(k) clearance for the DIRECT ANTIBIOTIC INFUSION KIT, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Summit Medical Products, Inc. (Salt Lake Cty, US). The FDA issued a Cleared decision on December 20, 2011, 68 days after receiving the submission on October 13, 2011. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K113043 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 2011
Decision Date December 20, 2011
Days to Decision 68 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5970

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