Product code NZW— General Hospital
BD PosiFlush Heparin Lock Flush Syringe
- Classification name
- Heparin, Vascular Access Flush
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Total cleared
- 7
- First cleared
- Most recent
FDA classification definition
“Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.”
Market context for product code NZW
FDA has cleared devices under product code NZW between 2003 and 2017, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2017
- 2014
- 2010
- 2009
- 2007
- 2003
Top applicants under product code NZW
Recent clearances under product code NZW
- K163591 — BD PosiFlush Heparin Lock Flush Syringe
- K133446 — HEPARIN LOCK / FLUSH SYRINGES
- K092938 — HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710
- K092491 — MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES
- K090680 — HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE
- K061497 — SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
- K023740 — SYREX PRE-FILLED SYRINGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.