510(k) K220772

HydroMID 4F Single Lumen Midline Catheter by Access Vascular, Inc. — Product Code FOZ

K220772 is an FDA 510(k) premarket notification submitted by Access Vascular, Inc. for the device "HydroMID 4F Single Lumen Midline Catheter". The FDA issued a decision of Substantially Equivalent on December 7, 2022. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Access Vascular, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2022
Date Received
March 16, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type