Cleared Traditional

UNI-PICC

K130034 · Health Line International Corporation · General Hospital
Mar 2013
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K130034 is an FDA 510(k) clearance for the UNI-PICC, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Health Line International Corporation (Centerville, US). The FDA issued a Cleared decision on March 8, 2013, 60 days after receiving the submission on January 7, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K130034 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2013
Decision Date March 08, 2013
Days to Decision 60 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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