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FDA 510(k)

AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE

K-Number: K111034 · 2011-07-14

ApplicantAm USA
Decision Date2011-07-14
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Am USA. It received FDA 510(k) clearance on 2011-07-14 under 510(k) number K111034. 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 AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE?

AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE is a medical device that received FDA 510(k) clearance on 2011-07-14. The listed applicant is Am USA. The 510(k) number is K111034.

When did AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE receive FDA 510(k) clearance?

AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE received FDA 510(k) clearance on 2011-07-14, under 510(k) number K111034.

Who is the listed applicant for AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE?

The FDA 510(k) record lists Am USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE?

The FDA product code for AM USA 0.9% SODIUM CHLORIDE FLUSH 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Am USA as applicant

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.

K1208360.9% SODIUM CHLORIDE FLISH SYRINGEK113555AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE

Related Devices (Code: NGT)

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.

K2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeBecton, Dickinson and CompanyK233623Praxiject™ 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.

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