510(k) K213085
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)