Cleared Abbreviated

HydroMID

K203069 · Access Vascular, Inc. · General Hospital
Feb 2021
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K203069 is an FDA 510(k) clearance for the HydroMID, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Access Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on February 8, 2021, 122 days after receiving the submission on October 9, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K203069 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 2020
Decision Date February 08, 2021
Days to Decision 122 days
Submission Type Abbreviated
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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