LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM

• K Number: K111603
• Device Name: LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM
• Manufacturer: EP DYNAMICS, INC.
• Date Cleared: 2012-08-23 ( 442 days)
• Product Code: DYB
• Regulation Number: 870.1340
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The EP Dynamics, Inc., LineBacker™ Transseptal Introducer is used to introduce various cardiovascular catheters into the left side of the heart through the interatrial septum.

Device Description

Not Found

AI/ML Overview

This is an FDA 510(k) clearance letter for a medical device (LineBacker Transseptal Introducer). This document does not contain the acceptance criteria or a study proving the device meets acceptance criteria.

FDA 510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on meeting specific performance criteria through a detailed study in the same way a PMA (Premarket Approval) might require. The letter primarily confirms that the FDA has reviewed the submission and found the device substantially equivalent for its stated indications for use.

Therefore, I cannot extract the requested information from the provided text.

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).