510(k) K213085

Introcan Safety 3 Closed IV Catheter by B.Braun Medical, Inc. — Product Code FOZ

K213085 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "Introcan Safety 3 Closed IV Catheter". The FDA issued a decision of Substantially Equivalent on Oct 25, 2021. 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 149 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 25, 2021
Date Received
Sep 24, 2021
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
510(k)