Cleared Traditional

VASU-PICC

K122423 · Medical Components, Inc. · General Hospital
Dec 2012
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K122423 is an FDA 510(k) clearance for the VASU-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 December 12, 2012, 125 days after receiving the submission on August 9, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K122423 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2012
Decision Date December 12, 2012
Days to Decision 125 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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