← Product Code [DXC](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC) · K962510

# HEARTPORT ENDOAORTIC CLAMP (K962510)

_Heartport, Inc. · DXC · Sep 11, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K962510

## Device Facts

- **Applicant:** Heartport, Inc.
- **Product Code:** [DXC](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC.md)
- **Decision Date:** Sep 11, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4450
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **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.

## Regulatory 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)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

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: (415) 306-7900
Fax Number: (415) 306-7905

## 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
Page 1

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K962510](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K962510)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com