Aspire Covered Stent and 718 Delivery System

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Vascular Architects Aspire Covered Stent and 718 Delivery System

510(k) Number

K031641 ↗

FDA Product Code

JCT

Device Class

Class II

Regulation

21 CFR Part 878.3720

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery System

  Class II

  FDA 510(k) K012544 Active Cleared 15 Nov 2001

• Modification to Vascular Architects Aspire Covered Stent and Contrilled Expansion Delivery System

  Class II

  FDA 510(k) K030567 Active Cleared 24 Mar 2003

• Aspire Covered Stent and Delivery Catheter

  Class II

  FDA 510(k) K003173 Active Cleared 13 Mar 2001

• Vascular Architects Periscope Device

  Class II

  FDA 510(k) K003719 Active Cleared 28 Feb 2001

• What clinical condition is the Aspire Covered Stent and 718 Delivery System intended to address in patients?

  The Aspire Covered Stent and 718 Delivery System is designed to maintain the tracheobronchial airway lumen in patients with strictures caused by malignant neoplasms. It provides structural support to prevent airway obstruction, helping restore and preserve breathing passages compromised by tumors.

• Is the Aspire Covered Stent and 718 Delivery System intended for single-use or reusable applications?

  The Aspire Covered Stent and 718 Delivery System is explicitly supplied as a single-use device. This ensures sterility and safety for clinical use in controlled environments like operating rooms or bronchoscopy suites, where it is intended to be deployed once per patient.

• Can this device be used in patients who require MRI imaging after placement, and why?

  No, the Aspire Covered Stent and 718 Delivery System is not MRI-safe. This means it should not be used in patients who require MRI imaging post-procedure, as the device could pose risks or interfere with MRI compatibility. Always follow manufacturer instructions for storage and handling to maintain functionality.

• What type of regulatory clearance does the Aspire Covered Stent and 718 Delivery System hold, and how does this affect its use?

  The Aspire Covered Stent and 718 Delivery System holds FDA 510(k) clearance (K031641) under device class II, with a product code of JCT. This clearance indicates it is considered substantially equivalent to a legally marketed predicate device and is regulated under traditional review procedures, ensuring it meets established safety and performance standards for clinical use.