Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe
FDA 510(k) K090680 · Becton, Dickinson & CO
510(k) numberK090680
Submission
- Device name
- Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe
- Applicant
- Becton, Dickinson & CO
Franklin Lakes, NJ, US - Received
- March 16, 2009
- Decision date
- June 10, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NZW – Heparin, Vascular Access Flush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Other 510(k)s with product code NZW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K163591 | BD PosiFlush Heparin Lock Flush SyringeNZW · Special | Becton, Dickinson and Company | 02/27/2017SE |
| K133446 | Heparin Lock / Flush SyringesNZW · Traditional | Excelsior Medical Corporation | 11/14/2014SE |
| K092938 | Heparin Lock Flush Solution Usp, Models 504401, 504411, 504505, 505701, 504901, 1710NZW · Traditional | App Pharmaceuticals, LLC | 06/18/2010SE |
| K092491 | Medefil's Heparin I.V. Flush Syringe 1 Unit/Ml; 10 Units/Ml; and 100 Units/Ml in Various…NZW · Traditional | Medefil, Inc. | 02/03/2010SE |
| K061497 | Syrex Heparin Lock Flush Syringe, 1 Unit/Ml & 2 Units/MlNZW · Traditional | Excelsior Medical Corp. | 02/23/2007SE |
| K023740 | Syrex Pre-Filled SyringeNZW · Traditional | Excelsior Medical Corp. | 05/13/2003SE |
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Questions and answers
When was Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe cleared by the FDA?
Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush Syringe (K090680) received a 510(k) decision of Substantially Equivalent on June 10, 2009, 86 days after the submission was received.
What is the product code of K090680?
The FDA product code is NZW – Heparin, Vascular Access Flush, a Class II (moderate risk) device regulated under 21 CFR 880.5200.