HEARTPORT ENDOAORTIC CLAMP

K964161 · Heartport, Inc. · DXC · Apr 4, 1997 · Cardiovascular

Device Facts

• Record ID: K964161
• Device Name: HEARTPORT ENDOAORTIC CLAMP
• Applicant: Heartport, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Apr 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopulmonary bypass.

Device Story

Endoaortic clamp catheter; used during cardiopulmonary bypass; occludes aorta via balloon inflation; delivers cardioplegic solution; monitors aortic root pressure. Operated by cardiac surgeons in OR. Provides aortic occlusion to facilitate cardiac surgery; enables cardioplegia delivery and pressure monitoring; improves surgical access and patient outcomes during bypass procedures.

Clinical Evidence

Bench testing only. Performance testing demonstrated with 95% confidence that the device meets or exceeds performance standards.

Technological Characteristics

Cardiopulmonary bypass vascular catheter; balloon-based occlusion mechanism; integrated lumens for cardioplegia delivery and pressure monitoring.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass requiring aortic occlusion, cardioplegia delivery, and aortic root pressure monitoring.

Regulatory Classification

Identification

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

Predicate Devices

• Heartport Endoaortic Clamp (K962510)
• Heartport Endoaortic Clamp (K955132)

Submission Summary (Full Text)

{0}

Endoaortic Clamp
APR - 4 1997
510(k) Notification

# Appendix A. 510(k) Summary of Safety and Effectiveness

## 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _________________________

## Applicant Information:

Date Prepared: October 16, 1996

Name: Heartport, Inc.

Address: 200 Chesapeake Drive
Redwood City, CA 94063

Contact Person: Kevin F. MacDonald

Phone Number: [phone]

Fax Number: [phone]

## Device Information:

Trade Name: Heartport Endoaortic Clamp™

Common Name: Endoaortic Clamp Catheter

Classification Name: Cardiopulmonary bypass vascular catheter

## Equivalent Devices:

Heartport Endoaortic Clamp - K962510

Heartport Endoaortic Clamp - K955132

## Intended Use:

Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopulmonary bypass.

## Comparison To Predicate Devices:

This device has the same intended use and technological characteristics as the predicate device.

Heartport, Inc.
CONFIDENTIAL
Page 12

{1}

Endoaortic Clamp
510(k) Notification

## Non-clinical Test Results:

Performance testing has demonstrated with 95% confidence that the Heartport Endoaortic Clamp™ will meet or exceed Heartport, Inc. performance standards.

## Test Conclusions:

Performance testing has demonstrated that the Endoaortic Clamp will function safely and effectively, while meeting the anticipated clinical requirements for the intended use.

Heartport, Inc.
CONFIDENTIAL
Page 13