Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sterile High-pressure Angiographic Syringes for Single-use

K-Number: K192657 · 2020-08-07

ApplicantShenzhen Boon Medical Supply Co., Ltd.
Decision Date2020-08-07
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sterile High-pressure Angiographic Syringes for Single-use is a medical device manufactured by Shenzhen Boon Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2020-08-07 under approval number K192657. 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 2020-08-07. It is manufactured by Shenzhen Boon Medical Supply Co., Ltd.. The 510(k) number is K192657.

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 2020-08-07, under approval number K192657.

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

Sterile High-pressure Angiographic Syringes for Single-use is manufactured by Shenzhen Boon Medical Supply 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

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT02710916 SD-OCT Multimodal Analysis in GLaucoma COMPLETED NCT06741657 A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways COMPLETED NCT07604922 Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease NOT_YET_RECRUITING

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)

Other Devices by Shenzhen Boon Medical Supply Co., Ltd.

K211564Sterile High-pressure Angiographic Syringes for Single-use K241109Single-use Sterile High-pressure Angiographic Syringes and Accessories

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.

↑