Cleared Traditional

HydroPICC 5F Dual Lumen Catheter

K213550 · Access Vascular, Inc. · General Hospital
May 2022
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K213550 is an FDA 510(k) clearance for the HydroPICC 5F Dual Lumen Catheter, 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 May 4, 2022, 177 days after receiving the submission on November 8, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K213550 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2021
Decision Date May 04, 2022
Days to Decision 177 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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