510(k) K260539

MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter by MedSource Labs, LLC — Product Code FOZ

K260539 is an FDA 510(k) premarket notification submitted by MedSource Labs, LLC for the device "MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter". The FDA issued a decision of Substantially Equivalent on July 9, 2026. 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. MedSource Labs, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2026
Date Received
February 17, 2026
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