Cleared Traditional

HydroPICC (PICC-142)

K193015 · Access Vascular, Inc. · General Hospital
Feb 2020
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K193015 is an FDA 510(k) clearance for the HydroPICC (PICC-142), 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, 2020, 114 days after receiving the submission on October 29, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K193015 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2019
Decision Date February 20, 2020
Days to Decision 114 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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