Heparin Lock / Flush Syringes
FDA 510(k) K133446 · Excelsior Medical Corporation
510(k) numberK133446
Submission
- Device name
- Heparin Lock / Flush Syringes
- Applicant
- Excelsior Medical Corporation
Neptune, NJ, US - Received
- November 12, 2013
- Decision date
- November 14, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
| K090680 | Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush SyringeNZW · Special | Becton, Dickinson & CO | 06/10/2009SE |
| 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 |
More from Excelsior Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K142620 | 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride…NGT · Traditional | 12/12/2014SE |
| K130975 | Swabcap and SwabflushQBP · Traditional | 12/24/2013SE |
| K101270 | Swabflsuh (3ML, 5ML, 10ML) Model 10331, 10351, 10311NGT · Traditional | 02/10/2011SE |
| K083508 | SwabcapQBP · Traditional | 04/28/2009SE |
| K082837 | Sterile Field Saline Pre-Filled Syringe(S)NGT · Special | 12/18/2008SE |
| K061497 | Syrex Heparin Lock Flush Syringe, 1 Unit/Ml & 2 Units/MlNZW · Traditional | 02/23/2007SE |
| K053120 | Sterile Field Saline and Heparin Lock Flush SyringesFOZ · Special | 12/09/2005SE |
| K023740 | Syrex Pre-Filled SyringeNZW · Traditional | 05/13/2003SE |
| K962938 | Excelsior Disposable Syringe W/Normal Saline (.9% Sodium Chloride)FOZ · Traditional | 10/25/1996SE |
| K942349 | Microbore Extension SetFPA · Traditional | 02/08/1995SE |
Questions and answers
When was Heparin Lock / Flush Syringes cleared by the FDA?
Heparin Lock / Flush Syringes (K133446) received a 510(k) decision of Substantially Equivalent on November 14, 2014, 367 days after the submission was received.
What is the product code of K133446?
The FDA product code is NZW – Heparin, Vascular Access Flush, a Class II (moderate risk) device regulated under 21 CFR 880.5200.