AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002

• K Number: K090867
• Device Name: AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002
• Manufacturer: EP DYNAMICS, INC.
• Date Cleared: 2009-07-30 ( 121 days)
• Product Code: DYB
• Regulation Number: 870.1340
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The EP Dynamics, Inc. AirBloc™ 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

The provided text is a 510(k) premarket notification letter from the FDA to EP Dynamics, Inc. regarding their AirBloc™ Transseptal Introducer. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is related to a traditional medical device (catheter introducer) and not an AI/ML software device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications. The information provided is typical for a traditional medical device submission, focusing on substantial equivalence to a predicate device based on its intended use and general controls, rather than performance metrics from a clinical study for an AI algorithm.

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).