510(k) K090680
K090680 is an FDA 510(k) premarket notification submitted by Becton, Dickinson & CO for the device "HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE". The FDA issued a decision of Substantially Equivalent on June 10, 2009. The device falls under product code NZW (Heparin, Vascular Access Flush), a Class II device regulated under 21 CFR 880.5200. Becton, Dickinson & CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2009
- Date Received
- March 16, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Heparin, Vascular Access Flush
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.