510(k) K192676
K192676 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "Introcan Safety 2 IV Catheter 18-24 gauge". The FDA issued a decision of Substantially Equivalent on Apr 1, 2020. 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
- Apr 1, 2020
- Date Received
- Sep 26, 2019
- 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
- 510(k)