Cleared Traditional

C3 Wave System

K170934 · Medical Components, Inc. (dba MedComp) · General Hospital
Dec 2017
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K170934 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 December 6, 2017, 251 days after receiving the submission on March 30, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K170934 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2017
Decision Date December 06, 2017
Days to Decision 251 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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