XXL Vascular Balloon Dilatation Catheter

• K Number: K150303
• Device Name: XXL Vascular Balloon Dilatation Catheter
• Manufacturer: BOSTON SCIENTIFIC CORP.
• Date Cleared: 2015-06-15 ( 129 days)
• Product Code: LIT
• Regulation Number: 870.1250
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the Boston Scientific Corporation's XXL Vascular Balloon Dilatation Catheter. It states that the device has been found substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, or details of any clinical studies (such as MRMC or standalone studies).

Therefore, I cannot extract the requested information from this document. The letter merely communicates the FDA's regulatory decision and outlines ongoing responsibilities for the manufacturer.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).