HEARTPORT ENDOCORONARY SINUS CATHETR

K964248 · Heartport, Inc. · DWF · Jan 22, 1997 · Cardiovascular

Device Facts

• Record ID: K964248
• Device Name: HEARTPORT ENDOCORONARY SINUS CATHETR
• Applicant: Heartport, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Jan 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The catheter is designed to provide occlusion of the coronary sinus, to deliver cardioplegic solution to the coronary sinus and to monitor the coronary sinus pressure during cardiopulmonary bypass.

Device Story

Catheter designed for coronary sinus occlusion; delivers cardioplegic solution; monitors coronary sinus pressure during cardiopulmonary bypass. Used in surgical settings by physicians. Provides localized delivery of cardioplegia and pressure monitoring to assist in cardiac 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; design features for occlusion, fluid delivery, and pressure monitoring.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass requiring coronary sinus occlusion, cardioplegic solution delivery, and coronary sinus pressure monitoring.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

• Endosinus Catheter (K961270)

Submission Summary (Full Text)

{0}

JAN 22 1997
Endocoronary Sinus™ Catheter
K964248
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: October 22, 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 Endocoronary Sinus Catheter
Common Name: Sinus Catheter
Classification Name: Cardiopulmonary bypass vascular catheter

## Equivalent Device:

Name: Endosinus Catheter
Manufacturer: Heartport, Inc.
Status: Post-enactment
510(k) # K961270
Cleared: June 18, 1996

Heartport, Inc.
CONFIDENTIAL
17

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Endocoronary Sinus™ Catheter
Appendices

# 510(k) Summary of Safety and Effectiveness (continued)

## Intended Use:

The catheter is designed to provide occlusion of the coronary sinus, to deliver cardioplegic solution to the coronary sinus and to monitor the coronary sinus pressure during cardiopulmonary bypass.

## Comparison To Predicate Devices:

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

## Non-clinical Test Results:

Performance testing has demonstrated with 95% confidence that the Endocoronary Sinus Catheter will meet or exceed Heartport’s performance standards.

## Test Conclusions:

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

Heartport, Inc.
CONFIDENTIAL
18