Heparin, Vascular Access Flush
The Heparin, Vascular Access Flush (product code NZW) is a heparin-based flush solution intended to enhance the performance of intravascular catheters and maintain catheter patency when not in active use. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 880.5200 within the General Hospital specialty. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NZW
- Device Class
- FDA class 2
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K163591 | BD PosiFlush Heparin Lock Flush Syringe | Feb 27, 2017 | Substantially Equivalent | Becton, Dickinson and Company |
| K133446 | HEPARIN LOCK / FLUSH SYRINGES | Nov 14, 2014 | Substantially Equivalent | Excelsior Medical Corporation |
| K092938 | HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 | Jun 18, 2010 | Substantially Equivalent | App Pharmaceuticals, LLC |
| K092491 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES | Feb 03, 2010 | Substantially Equivalent | Medefil, Inc. |
| K090680 | HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE | Jun 10, 2009 | Substantially Equivalent | Becton, Dickinson & CO |
| K061497 | SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML | Feb 23, 2007 | Substantially Equivalent | Excelsior Medical Corp. |
| K023740 | SYREX PRE-FILLED SYRINGE | May 13, 2003 | Substantially Equivalent | Excelsior Medical Corp. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.