Cleared Traditional

Biowy PlCC Catheter

K173956 · Biowy Corporation · General Hospital
May 2018
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K173956 is an FDA 510(k) clearance for the Biowy PlCC Catheter, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Biowy Corporation (Lake Forest, US). The FDA issued a Cleared decision on May 21, 2018, 144 days after receiving the submission on December 28, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K173956 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2017
Decision Date May 21, 2018
Days to Decision 144 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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