NZW
7 FDA 510(k) clearances · Product code
187 daysmedian time to decision
367 days90th percentile
7clearances measured
FDA profile
- Official device name
- Heparin, Vascular Access Flush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Medical specialty
- General Hospital
- FDA definition
- Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
- Adverse events (MAUDE)
- 2012: 9 · 2013: 15 · 2014: 8 · 2018: 19 · 2019: 19 · 2022: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BD PosiFlush Heparin Lock Flush Syringe (K163591) | Becton, Dickinson and Company | 2017-02-27 |
| HEPARIN LOCK / FLUSH SYRINGES (K133446) | Excelsior Medical Corporation | 2014-11-14 |
| HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 (K092938) | App Pharmaceuticals, LLC | 2010-06-18 |
| MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES (K092491) | Medefil, Inc. | 2010-02-03 |
| HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE (K090680) | Becton, Dickinson & CO | 2009-06-10 |
| SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML (K061497) | Excelsior Medical Corp. | 2007-02-23 |
| SYREX PRE-FILLED SYRINGE (K023740) | Excelsior Medical Corp. | 2003-05-13 |
Track NZW automatically
Every clearance here is in the API, with alerts when new ones post.