Cleared Traditional

Vygon PICCs

K172899 · Vygon USA · General Hospital
Feb 2018
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K172899 is an FDA 510(k) clearance for the Vygon PICCs, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Vygon USA (Lansdale, US). The FDA issued a Cleared decision on February 26, 2018, 157 days after receiving the submission on September 22, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K172899 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2017
Decision Date February 26, 2018
Days to Decision 157 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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