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FDA 510(k)

Disposable High Pressure Injector Syringe

K-Number: K152906 · 2016-11-22

ApplicantWuxi Yushou Medical Appliances Co., Ltd.
Decision Date2016-11-22
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Disposable High Pressure Injector Syringe is a medical device manufactured by Wuxi Yushou Medical Appliances Co., Ltd.. It received FDA 510(k) clearance on 2016-11-22 under approval number K152906. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable High Pressure Injector Syringe?

Disposable High Pressure Injector Syringe is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by Wuxi Yushou Medical Appliances Co., Ltd.. The 510(k) number is K152906.

When was Disposable High Pressure Injector Syringe approved by the FDA?

Disposable High Pressure Injector Syringe received FDA 510(k) clearance on 2016-11-22, under approval number K152906.

What company makes Disposable High Pressure Injector Syringe?

Disposable High Pressure Injector Syringe is manufactured by Wuxi Yushou Medical Appliances Co., Ltd..

What is the FDA product code for Disposable High Pressure Injector Syringe?

The FDA product code for Disposable High Pressure Injector Syringe is DXT.

Related Clinical Trials

NCT06411054 The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA RECRUITING NCT07548892 Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children NOT_YET_RECRUITING NCT06918587 A Comparative Evaluation of Pharmacokinetics and Immunogenicity. COMPLETED NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

Other Devices by Wuxi Yushou Medical Appliances Co., Ltd.

K210679Medical Face Mask

Related Devices (Code: DXT)

K160190Sunmed Control SyringesSunny Medical Device (Shenzhen) Co., Ltd. K161471MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc. K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. K160107DiamondTOUCH Inflation Device and Fluid Dispensing SyringeMerit Medical Systems, Inc. K152978DeRoyal Angiography KitsDeroyal Industries, Inc. K153141DyeVert Contrast Modulation SystemOsprey Medical, Inc.

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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