← Product Code [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF) · K971041

# CHASE CORONARY OSTIAL PERFUSION CANNULA (K971041)

_Chase Medical, Inc. · DWF · May 13, 1997 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K971041

## Device Facts

- **Applicant:** Chase Medical, Inc.
- **Product Code:** [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF.md)
- **Decision Date:** May 13, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4210
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Therapeutic

## Indications for Use

The Coronary Ostial Perfusion Cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivery of cardioplegia solutions directly to the coronary arteries.

## Device Story

Device consists of basket-style tip attached to malleable stainless steel tube; terminates in locking female luer fitting. Used during cardiopulmonary bypass surgery by surgeons to deliver cardioplegia solutions directly to coronary arteries. Device provides localized perfusion; ensures secure connection via luer fitting. Benefits include reliable delivery of cardioplegic agents to maintain myocardial protection during bypass.

## Clinical Evidence

Bench testing only. Testing included leak testing at 10 psi, luer connection compliance with ANSI/HIMA MD70.1-1983, package integrity testing per ASTM F1140-88, shipping/distribution vibration and drop tests, and accelerated aging for two-year shelf life validation.

## Technological Characteristics

Malleable stainless steel tube with basket-style tip. Locking female luer fitting compliant with ANSI/HIMA MD70.1-1983. Sterilization via 100% Ethylene Oxide (Overkill Method, SAL 10⁻⁶). Packaging: Tyvek/Polymylar.

## Regulatory 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

- Medtronic/DLP Coronary Ostial Perfusion Cannula

## Submission Summary (Full Text)

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K971041
MAY 13 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

## CHASE CORONARY OSTIAL PERFUSION CANNULA

### I. General Information

A. Generic Name: Coronary Ostial Perfusion Cannula
B. Trade Name of Device: Chase Coronary Ostial Perfusion Cannula
C. Applicant’s Name and Address: CHASE MEDICAL, INC., Richardson, TX
D. Pre-market Notification Number: Not assigned

### II. Indication for Use:

The Coronary Ostial Perfusion Cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivery of cardioplegia solutions directly to the coronary arteries.

### III. Device Description

These cannulae consist of a basket style tip attached to a malleable stainless steel tube. The cannula terminates with a locking female luer fitting.

### IV. Device Classification:

Class II device

### V. Safety and Effectiveness:

Substantial Equivalence: This device has been shown to be substantially equivalent to the Medtronic/DLP Coronary Ostial Perfusion Cannula.

### VI. Other Safety and Effectiveness Data:

Materials: All material are identical to the predicate device.
Sterilization: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶

## Functional Testing

All functional characteristics of the Chase Coronary Ostial Perfusion Cannula are non-differentiable as compared with the predicate.

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# SUMMARY OF SAFETY AND EFFECTIVENESS

|  Leak Test Requirements: | No leaks at 10 psi air on Chase device.  |
| --- | --- |
|  Luer Connections: | Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Tape Fittings  |
|  Package Integrity: | Tyvek/Polymylar passed burst test per ASTM F1140-88  |
|  Shipping & Distribution Testing: | Per National Safe Transit Ass. vibration and drop tests  |
|  Accelerated Aging: | Two year shelf life  |

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K971041](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K971041)

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