Cleared Special

MEDCOMP VASCU-PICC & MIDLINE CATHETERS

K121094 · Medical Components, Inc. · General Hospital
Jun 2012
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K121094 is an FDA 510(k) clearance for the MEDCOMP VASCU-PICC & MIDLINE CATHETERS, 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 June 6, 2012, 57 days after receiving the submission on April 10, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K121094 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2012
Decision Date June 06, 2012
Days to Decision 57 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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