510(k) K220626

Introcan Safety IV Catheter by B.Braun Medical, Inc. — Product Code FOZ

K220626 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "Introcan Safety IV Catheter". The FDA issued a decision of Substantially Equivalent on May 14, 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. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2022
Date Received
March 4, 2022
Clearance Type
Special
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