510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NZWClass II

Heparin, Vascular Access Flush

21 CFR 880.5200 / General Hospital
FDA source (opens on fda.gov)

NZW is the FDA product code for Heparin, Vascular Access Flush, a class II device type, regulated under 21 CFR 880.5200. FDA's definition for this code reads: "Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 44 recalls.

Classification record

Product code
NZW
Device name
Heparin, Vascular Access Flush
FDA definition
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
44

Clearances, product code NZW

By decision year
7 clearances under product code NZW with a decision year between 2003 and 2017, 2010 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NZW by decision year
YearClearances
20031
20071
20091
20102
20141
20171

Applicants with the most clearances

Product code NZW
Applicants holding the most 510(k) clearances under product code NZW
ApplicantClearances
Excelsior Medical LLC3
Becton Dickinson & Co2
Fresenius Kabi USA, LLC1
Medefil, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code