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)

AXIOS Stent and Electrocautery Enhanced Delivery System

K-Number: K192043 · 2019-08-26

ApplicantBoston Scientific Corporation
Decision Date2019-08-26
Product CodePCU
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AXIOS Stent and Electrocautery Enhanced Delivery System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-08-26 under approval number K192043. 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 Electrocautery Enhanced Delivery System?

AXIOS Stent and Electrocautery Enhanced Delivery System is a medical device that received FDA 510(k) clearance on 2019-08-26. It is manufactured by Boston Scientific Corporation. The 510(k) number is K192043.

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

AXIOS Stent and Electrocautery Enhanced Delivery System received FDA 510(k) clearance on 2019-08-26, under approval number K192043.

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

The FDA product code for 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: 41813232 Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review. Journal of medical Internet research (2026) 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: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025) PMID: 40069892 Enhanced mitochondrial function and delivery from adipose-derived stem cell spheres via the EZH2-H3K27me3-PPARγ pathway for advanced therapy. Stem cell research & therapy (2025)

Other Devices by Boston Scientific Corporation

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete K163174Emerge PTCA Dilatation Catheter K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 K162404Express SD Biliary Monorail Premounted Stent System K160823NC Quantum Apex PTCA Dilatation Catheter K160514OptiCross 18, 30 MHz Peripheral Imaging Catheter

View all 176 devices →

Related Devices (Code: PCU)

K163272AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation K181905AXIOS Stent and Delivery System, AXIOS 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.

↑