Cleared Traditional

HydroMID 4F Single Lumen Midline Catheter

K220772 · Access Vascular, Inc. · General Hospital
Dec 2022
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K220772 is an FDA 510(k) clearance for the HydroMID 4F Single Lumen Midline Catheter, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Access Vascular, Inc. (Ballerica, US). The FDA issued a Cleared decision on December 7, 2022, 266 days after receiving the submission on March 16, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K220772 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2022
Decision Date December 07, 2022
Days to Decision 266 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200

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