510(k) K191658
K191658 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "IV Sets not made with PVC". The FDA issued a decision of Substantially Equivalent on Mar 19, 2020. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. B.Braun Medical, Inc. has 149 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 19, 2020
- Date Received
- Jun 21, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)