← Product Code [MJN](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN) · K960422

# PRUITT SAFETY OCCLUSION CATHETER (K960422)

_Ideas For Medicine, Inc. · MJN · Aug 7, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K960422

## Device Facts

- **Applicant:** Ideas For Medicine, Inc.
- **Product Code:** [MJN](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN.md)
- **Decision Date:** Aug 7, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4450
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Therapeutic

## Indications for Use

The intended use of this device is for occlusion of the internal carotid artery during endarterectomy.

## Device Story

Single lumen balloon catheter; features external safety balloon inflating at 17 psi to prevent intraluminal balloon overinflation. Used in surgical setting (OR) by vascular surgeons during carotid endarterectomy. Provides vessel occlusion as alternative to mechanical clamping. Benefits patient by reducing risk of balloon rupture/overinflation during procedure.

## Clinical Evidence

Bench testing only; biocompatibility testing performed per ISO-10993.

## Technological Characteristics

Single lumen balloon catheter; external safety balloon mechanism (17 psi threshold); sterile, non-pyrogenic; materials biocompatibility tested per ISO-10993.

## Regulatory Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

## Predicate Devices

- Pruitt Inahara Shunt

## Submission Summary (Full Text)

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AUG - 7 1996
K960422
Ideas for Medicine, Inc.
Pruitt Safety Occlusion Catheter
510(k) Notification

# SAFETY and EFFECTIVENESS SUMMARY

## PROPRIETARY NAME:

Pruitt Safety Occlusion Catheter

## COMMON USUAL NAME:

Vascular Catheter

## CLASSIFICATION:

Class II

## CLASSIFICATION NUMBER:

74.DXG

## DEVICE DESCRIPTION:

The Pruitt Safety Occlusion Catheter is a single lumen balloon catheter. There is an external safety balloon designed to inflate when the intraluminal balloon reaches 17 psi. This reduces the possibility of balloon overinflation. All materials have been used by Ideas for Medicine, Inc. for many years to manufacture other Class II devices. All materials have been subject to Biocompatibility testing. (1) Every lot is supplied sterile and non-pyrogenic.

## SUBSTANTIAL EQUIVALENT:

The intended use of this device is for occlusion of the internal carotid artery during endarterectomy. The Pruitt Inahara Shunt is a balloon shunt that provides a temporary bypass during carotid endarterectomy and features the external safety balloon. The Pruitt Occlusion Catheter provides vessel occlusion without shunting. The Pruitt Safety Occlusion Catheter combines the 2 devices and provides an alternative to clamping during carotid endarterectomy where the surgeon chooses not to shunt.

1 "Use of International Standard ISO-10993, Biological Evaluation of Medical Device, Part I, Evaluation and Testing" for Devices in Contact with Blood (short term duration).

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K960422](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K960422)

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