Cleared Special

C3 Wave System

K180567 · Medical Components, Inc. (dba MedComp) · General Hospital
Apr 2018
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K180567 is an FDA 510(k) clearance for the C3 Wave System, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Medical Components, Inc. (dba MedComp) (Harleysville, US). The FDA issued a Cleared decision on April 12, 2018, 38 days after receiving the submission on March 5, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K180567 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2018
Decision Date April 12, 2018
Days to Decision 38 days
Submission Type Special
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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