Cleared Traditional

3F PRO-PICC

K123617 · Medical Components, Inc. · General Hospital
May 2013
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K123617 is an FDA 510(k) clearance for the 3F PRO-PICC, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on May 15, 2013, 173 days after receiving the submission on November 23, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K123617 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2012
Decision Date May 15, 2013
Days to Decision 173 days
Submission Type Traditional
Review Panel General Hospital (HO)
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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