BRAUN PERCUTANEOUS INTRODUCER SET

• K Number: K961745
• Device Name: BRAUN PERCUTANEOUS INTRODUCER SET
• Manufacturer: B. BRAUN MEDICAL, INC.
• Date Cleared: 1996-09-17 ( 134 days)
• Product Code: DYB
• Regulation Number: 870.1340
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K810460 , K894446 , K780126 , K850820 , K932733
• Predicate For: N/A

Intended Use

The Braun Percutaneous Introducer Kits are designed to facilitate percutaneous introduction of devices into the vasculature.

Device Description

Braun Percutaneous Introducer Kits consist of an introducer sheath packaged with a corresponding dilator. A guidewire and introducer needle may also be packaged with the sheath and dilator.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Braun Percutaneous Introducer Set) and primarily focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports for AI/ML devices.

Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a traditional medical device, not an AI/ML powered device, and thus does not contain the specific study design elements you've asked for.

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).