(183 days)
Use of the endoarterial return cannula is indicated for patients undergoing endovascular cardiopulmonary bypass. The endoarterial return cannula serves to deliver oxygenated blood for cardiopulmonary bypass during cardiac surgery and to allow hemostatic introduction, removal and securing of the endoaortic clamp catheter into the femoral artery.
This post-enactment device is an extracorporeal cannula used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment.
This document does not contain an AI/ML device, therefore, the requested information elements cannot be extracted.
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Appendix A. 510(k) Summary of Safety and Effectiveness MAY 1 0 1996
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:
November 6, 1995 Date Prepared:
| Name: | Heartport, Inc. |
|---|---|
| Address: | 200 Chesapeake Drive |
| Redwood City, CA 94063 |
| Contact Person: | David A. Tucker |
|---|---|
| Phone Number: | (415) 306-7900 |
| Fax Number: | (415) 306-7905 |
Device Information:
| Trade Name: | Endoarterial Return Cannula |
|---|---|
| Common Name: | Arterial Return Cannula |
| Classification Name: | Cardiopulmonary bypass vascular cannula |
Equivalent Devices:
Bio-Medicus Cannula-Tubing Tuohy-Borts Y Hemostasis Valve
Device Descriptions:
Cannula-Tubing
This post-enactment device is an extracorporeal cannula used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment.
Tuohy-Borts Y Hemostasis Valve
This post-enactment device is a hemostatic valve mounted on a "Y" connector attached on the distal (hub) end of a guiding (large bore) catheter. The device is intended for use in: pressure monitoring, flushing, infusion, and guiding catheter insertion for balloon dilatation angioplasty.
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510(k) Summary of Safety and Effectiveness (continued)
Intended Use:
Use of the endoarterial return cannula is indicated for patients undergoing endovascular cardiopulmonary bypass. The endoarterial return cannula serves to deliver oxygenated blood for cardiopulmonary bypass during cardiac surgery and to allow hemostatic introduction, removal and securing of the endoaortic clamp catheter into the femoral artery.
Comparison To Predicate Devices:
The Endoarterial Return Cannula is not significantly changed from the predicates. The only difference is the addition of an inner and outer tip coating to enhance lubricity during insertion of catheters. The Endoarterial Return Cannula provides the surgeon with one device that can be utilized to both introduce catheters and maintain cardiopulmonary bypass.
Non-clinical Test Results:
Performance testing has demonstrated with 95% confidence that the endoarterial return cannula will meet or exceed Heartport, Inc. performance standards.
Test Conclusions:
Performance testing has demonstrated that the endoarterial return cannula will function safely and efficaciously, while meeting the anticipated clinical requirements for the intended use.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
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.(b)
Classification. Class II (performance standards).