Cleared Special

1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC

K120980 · Medical Components, Inc. · General Hospital
May 2012
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K120980 is an FDA 510(k) clearance for the 1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-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 2, 2012, 30 days after receiving the submission on April 2, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K120980 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2012
Decision Date May 02, 2012
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement

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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