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FDA 510(k)

AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System

K-Number: K181905 · 2019-03-25

ApplicantBoston Scientific Corporation
Decision Date2019-03-25
Product CodePCU
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-03-25 under approval number K181905. The device is classified under product code PCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System?

AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System is a medical device that received FDA 510(k) clearance on 2019-03-25. It is manufactured by Boston Scientific Corporation. The 510(k) number is K181905.

When was AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System approved by the FDA?

AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System received FDA 510(k) clearance on 2019-03-25, under approval number K181905.

What company makes AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System?

AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System is manufactured by Boston Scientific Corporation.

What is the FDA product code for AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System?

The FDA product code for AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System is PCU.

Related Clinical Trials

NCT03736226 A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China ACTIVE_NOT_RECRUITING NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT07611968 Prospective Evaluation of Physician Modified Endografts for Aortic Disease NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 38767890 Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Journal of the American Medical Informatics Association : JAMIA (2024) PMID: 25262248 Unique device identifiers for coronary stent postmarket surveillance and research: a report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier demonstration. American heart journal (2014)

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Related Devices (Code: PCU)

K163272AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation K192043AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation K203132AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation K220112AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation K252648Niti-S SPAXUS StentTaewoong Medical 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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