BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870

• K Number: K062852
• Device Name: BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870
• Manufacturer: ONSET MEDICAL CORPORATION
• Date Cleared: 2007-02-23 ( 151 days)
• Product Code: DYB
• Regulation Number: 870.1340
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The Onset Balloon Expandable Transseptal Introducer (BETI) is intended to establish a conduit, into the left side of the heart, through the inter-atrial septum, for the introduction of various cardiovascular catheters.

Device Description

Onset Expandable Transseptal Introducer (BETI)

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. The document is an FDA 510(k) clearance letter for the Onset Medical Corporation's Onset Expandable Transseptal Introducer (BETI), confirming its substantial equivalence to a predicate device. It defines the device’s indications for use but does not detail any studies or performance metrics the manufacturer may have submitted as part of their 510(k) application.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).