STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION

• K Number: K991291
• Device Name: STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION
• Manufacturer: CONWAY STUART MEDICAL, INC.
• Date Cleared: 1999-07-14 ( 90 days)
• Product Code: GEI
• Regulation Number: 878.4400
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

Indicated for coagulation of tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Description

Conway Stuart Medical Model C8 Needle Inflatable Basket Catheter Electrode with Aspiration

AI/ML Overview

I'm sorry, but without further input, I cannot furnish an answer. The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called the "Stretta Model C8 Needle Inflatable Basket Catheter Electrode with Aspiration." This letter confirms the device's substantial equivalence to previously marketed devices and outlines regulatory responsibilities. However, it does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. Therefore, I cannot construct an answer based on the provided text.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.