510(k) K163591

Device: BD PosiFlush Heparin Lock Flush Syringe
Applicant: Becton Dickinson And Company
510(k) number: K163591
Product code: NZW
Decision: Substantially Equivalent (SESE)
Decision date: 2017-02-27
Date received: 2016-12-20
Regulation: 880.5200
Classification name: Heparin, Vascular Access Flush
Medical specialty: General Hospital
Review panel: General Hospital
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Aakash Jain
Address: 1 Becton Dr. Franklin Lakes NJ US 07045 07045

FDA Registration Numbers#

1423982
3011689956
3008518459
3012421607
2243072
2027791
1911916
1423507

Source Documents#

Other 510(k) Records For Product Code NZW #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K133446	HEPARIN LOCK / FLUSH SYRINGES	Excelsior Medical Corporation	2014-11-14
K092938	HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710	App Pharmaceuticals, LLC	2010-06-18
K092491	MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES	Medefil, Inc.	2010-02-03
K090680	HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE	Becton, Dickinson & CO	2009-06-10
K061497	SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML	Excelsior Medical Corp.	2007-02-23
K023740	SYREX PRE-FILLED SYRINGE	Excelsior Medical Corp.	2003-05-13

Legacy Summary#

summary

FDA Review#

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