510(k) K090680

HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE by Becton, Dickinson & CO — Product Code NZW

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.