Cleared Traditional

5 FR Dual Lumen Piper PICC

K181904 · Piper Access, LLC · General Hospital
Sep 2018
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K181904 is an FDA 510(k) clearance for the 5 FR Dual Lumen Piper PICC, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Piper Access, LLC (Salt Lake City, US). The FDA issued a Cleared decision on September 25, 2018, 71 days after receiving the submission on July 16, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K181904 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2018
Decision Date September 25, 2018
Days to Decision 71 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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