Cleared Traditional

HydroPICC

K172885 · Access Vascular, Inc. · General Hospital
Feb 2018
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K172885 is an FDA 510(k) clearance for the HydroPICC, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Access Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on February 20, 2018, 152 days after receiving the submission on September 21, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K172885 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2017
Decision Date February 20, 2018
Days to Decision 152 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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