FDA 510(k)

0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe

K-Number: K153481 · 2016-04-04

Decision Date2016-04-04

Product CodeNGT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2016-04-04 under 510(k) number K153481. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe?

0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe is a medical device that received FDA 510(k) clearance on 2016-04-04. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K153481.

When did 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe receive FDA 510(k) clearance?

0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe received FDA 510(k) clearance on 2016-04-04, under 510(k) number K153481.

Who is the listed applicant for 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe?

The FDA product code for 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe is NGT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05957406SMART TRENDS StudyCOMPLETED NCT06492746Personal BP - CAI StudyRECRUITING NCT07148323HemoSphere Alta StudyRECRUITING NCT07216573The Continuity StudyRECRUITING NCT07317648ClearSight NextGen1 StudyCOMPLETED

Other records listing Becton, Dickinson and Company as applicant

PMA P160037KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS K260128BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube K260184Onclarity™ Self-Collection Kit K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

View all 100 devices →

Related Devices (Code: NGT)

K2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeBecton, Dickinson and Company K233623Praxiject™ SP 0.9% NaClMedxl, Inc.K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt. , Ltd.K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd.K230756TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd.K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.