510(k) K170336
K170336 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector". The FDA issued a decision of Substantially Equivalent on Mar 10, 2017. 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. Becton, Dickinson And Company has 329 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 10, 2017
- Date Received
- Feb 2, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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)