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FDA 510(k)

Sterile High-pressure Angiographic Syringes for single-use

K-Number: K201395 · 2020-10-28

ApplicantYouwo (Guangzhou) Medical Device Co., Ltd.
Decision Date2020-10-28
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sterile High-pressure Angiographic Syringes for single-use is a medical device manufactured by Youwo (Guangzhou) Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2020-10-28 under approval number K201395. 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 Sterile High-pressure Angiographic Syringes for single-use?

Sterile High-pressure Angiographic Syringes for single-use is a medical device that received FDA 510(k) clearance on 2020-10-28. It is manufactured by Youwo (Guangzhou) Medical Device Co., Ltd.. The 510(k) number is K201395.

When was Sterile High-pressure Angiographic Syringes for single-use approved by the FDA?

Sterile High-pressure Angiographic Syringes for single-use received FDA 510(k) clearance on 2020-10-28, under approval number K201395.

What company makes Sterile High-pressure Angiographic Syringes for single-use?

Sterile High-pressure Angiographic Syringes for single-use is manufactured by Youwo (Guangzhou) Medical Device Co., Ltd..

What is the FDA product code for Sterile High-pressure Angiographic Syringes for single-use?

The FDA product code for Sterile High-pressure Angiographic Syringes for single-use is DXT.

Related Clinical Trials

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Related Devices (Code: DXT)

K152906Disposable High Pressure Injector SyringeWuxi Yushou Medical Appliances Co., Ltd. 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.

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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