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FDA 510(k)

Matreneu Percutaneous Balloon Compression Kit

K-Number: K220920 · 2022-09-07

ApplicantShenzhen Shineyard Medical Device Co. , Ltd.
Decision Date2022-09-07
Product CodeHAO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Matreneu Percutaneous Balloon Compression Kit is a medical device manufactured by Shenzhen Shineyard Medical Device Co. , Ltd.. It received FDA 510(k) clearance on 2022-09-07 under approval number K220920. The device is classified under product code HAO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Matreneu Percutaneous Balloon Compression Kit?

Matreneu Percutaneous Balloon Compression Kit is a medical device that received FDA 510(k) clearance on 2022-09-07. It is manufactured by Shenzhen Shineyard Medical Device Co. , Ltd.. The 510(k) number is K220920.

When was Matreneu Percutaneous Balloon Compression Kit approved by the FDA?

Matreneu Percutaneous Balloon Compression Kit received FDA 510(k) clearance on 2022-09-07, under approval number K220920.

What company makes Matreneu Percutaneous Balloon Compression Kit?

Matreneu Percutaneous Balloon Compression Kit is manufactured by Shenzhen Shineyard Medical Device Co. , Ltd..

What is the FDA product code for Matreneu Percutaneous Balloon Compression Kit?

The FDA product code for Matreneu Percutaneous Balloon Compression Kit is HAO.

Related Clinical Trials

NCT06353594 Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI RECRUITING NCT07587099 Single vs. Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Intervention With DCB-only Strategy (KONG-FREEDOM-I) RECRUITING NCT06959524 AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions RECRUITING NCT06710210 Hybrid Percutaneous Coronary Intervention Combining a Bioresorbable Scaffold With Drug-coated Balloons Versus a Conventional Drug-eluting Stent-based Strategy in Patients With Long and Diffuse Coronary Artery Disease RECRUITING NCT07539324 Clinical Impact of DCB-based Versus DES-based Intervention in Patients With MVCAD NOT_YET_RECRUITING NCT06798753 Occlusion Balloon vs. 5FR Ureteral Catheter COMPLETED

Related PubMed Literature

PMID: 25499024 Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix® drug coated balloon. Cardiovascular revascularization medicine : including molecular interventions (2014)

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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