HEARTPORT ENDOAORTIC CLAMP

K962510 · Heartport, Inc. · DXC · Sep 11, 1996 · Cardiovascular

Device Facts

• Record ID: K962510
• Device Name: HEARTPORT ENDOAORTIC CLAMP
• Applicant: Heartport, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Sep 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. Functions: aortic occlusion, cardioplegic solution delivery, aortic root pressure monitoring. Operated by surgeons in clinical settings. Device provided preassembled with accessories in single sterile package. Benefits: streamlined surgical workflow via integrated components.

Clinical Evidence

Bench testing only; performance testing demonstrated with 95% confidence that the device meets or exceeds Heartport, Inc. performance standards.

Technological Characteristics

Cardiopulmonary bypass vascular catheter; sterile, preassembled kit. No specific materials or software described.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass requiring aortic occlusion, cardioplegic solution 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 (Catalog Number 01055)

Submission Summary (Full Text)

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Endoaortic Clamp
SEP 11 1996
K962510
Appendices

# 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: June 26, 1996

Name: Heartport, Inc.
Address: 200 Chesapeake Drive
Redwood City, CA 94063

Contact Person: Robert J. Chin
Phone Number: [phone]
Fax Number: [phone]

## Device Information:

Trade Name: Endoaortic Clamp (Catalog Number 02055)
Common Name: Endoaortic Clamp Catheter
Classification Name: Cardiopulmonary bypass vascular catheter

## Equivalent Devices:

Heartport Endoaortic Clamp (Catalog Number 01055)

## Intended Use:

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

## Comparison To Predicate Devices:

The modifications to the predicate device provides the surgeon with an endoaortic clamp already preassembled with the necessary accessories in one sterile package.

## Non-clinical Test Results:

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

## Test Conclusions:

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

Heartport, Inc.
CONFIDENTIAL
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