510(k) K253235

Introcan Safety® Deep Access XL IV Catheter by B.Braun Medical, Inc. — Product Code FOZ

K253235 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "Introcan Safety® Deep Access XL IV Catheter". The FDA issued a decision of Substantially Equivalent on May 15, 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. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2026
Date Received
September 29, 2025
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