HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM

K962858 · Heartport, Inc. · DXC · Sep 30, 1996 · Cardiovascular

Device Facts

• Record ID: K962858
• Device Name: HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM
• Applicant: Heartport, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Sep 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Heartport Endovascular Cardiopulmonary Bypass Systems are indicated for use in patients undergoing cardiac surgery requiring cardiopulmonary bypass and an arrested heart. The system consists of a set of catheters, cannulae and accessories that permits a patient to be maintained on cardiopulmonary bypass and the patient’s heart to be arrested without the need for a median sternotomy.

Device Story

System comprises catheters, cannulae, and accessories for cardiopulmonary bypass and cardioplegic arrest; enables minimally invasive cardiac surgery by eliminating need for median sternotomy. Used in surgical settings by cardiac surgeons. Components include endovascular clamps, vents, arterial return cannulae, venous drainage cannulae, and sinus catheters. System maintains patient circulation and facilitates heart arrest during procedures.

Technological Characteristics

Kit of catheters, cannulae, and accessories for cardiopulmonary bypass. Mechanical components; no electronic, software, or energy-based sensing/actuation described.

Indications for Use

Indicated for patients undergoing cardiac surgery requiring cardiopulmonary bypass and an arrested heart, allowing for procedures without median sternotomy.

Regulatory Classification

Identification

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

Predicate Devices

• Heartport Endoartic Clamp (K955132)
• Heartport Endopulmonary Vent (K961245)
• Heartport Endoarterial Return Cannula (K955121)
• Medtronic DLP Venous Drainage Cannula (K875353)
• Heartport Endosinus Catheter (K961270)

Submission Summary (Full Text)

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K962858
SEP 30 1996
Endovascular Cardiopulmonary Bypass Systems
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: July 19, 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: Endovascular Cardiopulmonary Bypass Systems
Common Name: Cardiopulmonary bypass catheter kits
Classification Name: Cardiopulmonary bypass vascular catheter

## Equivalent Devices:

The Heartport Endovascular Antegrade Cardiopulmonary Bypass System is composed of the following commercially available bypass catheters, cannulae and accessories:

- Heartport Endoartic Clamp (K955132)
- Heartport Endopulmonary Vent (K961245)
- Heartport Endoarterial Return Cannula (K955121)
- Medtronic DLP Venous Drainage Cannula (K875353) or a substantially equivalent Heartport manufactured device

The Heartport Endovascular Antegrade/Retrograde Cardiopulmonary Bypass System consists of the above Antegrade Kit in addition to:

- Heartport Endosinus Catheter (K961270)

Heartport, Inc.
CONFIDENTIAL
10

{1}

Endovascular Cardiopulmonary Bypass Systems
Appendices

## Intended Use:

The Heartport Endovascular Cardiopulmonary Bypass Systems are indicated for use in patients undergoing cardiac surgery requiring cardiopulmonary bypass and an arrested heart. The system consists of a set of catheters, cannulae and accessories that permits a patient to be maintained on cardiopulmonary bypass and the patient’s heart to be arrested without the need for a median sternotomy.

## Comparison To Predicate Devices:

There are no changes from the predicate devices other than the shelf packaging and its label.

Heartport, Inc.
CONFIDENTIAL
11