TEMPORARY OCCLUSION BALLOON SYSTEM

• K Number: K972777
• Device Name: TEMPORARY OCCLUSION BALLOON SYSTEM
• Manufacturer: PERCUSURGE, INC.
• Date Cleared: 1998-03-11 ( 229 days)
• Product Code: MJN , DAT
• Regulation Number: 870.4450
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The PercuSurge Temporary Occlusion Balloon (TOB) System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids with or without vessel occlusion. The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature (see WARNINGS).

Device Description

PercuSurge Temporary Occlusion Balloon (TOB) System

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the PercuSurge Temporary Occlusion Balloon (TOB) System. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature (see WARNINGS)." and "The safety and effectiveness of the PercuSurge Temporary Occlusion Balloon (TOB) System, used as an adjunct in interventional procedures, have NOT been established."

Therefore, I cannot provide the requested information based on the provided text. The document is about the regulatory clearance for the device's intended use in the peripheral vasculature, not about detailed performance studies or acceptance criteria that would typically be found in a clinical study report or a more extensive submission.

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).