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Chase Coronary Sinus Perfusion Cannula

FDA 510(k)

Class II (US FDA 510(k))

510(k) K964199

by Chase Medical, Inc.

Identifiers

510(k) Number
K964199 FDA 510(k)
FDA Product Code
DWF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4210 FDA 510(k)
Regulation Number
870.4210 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Chase Coronary Sinus Perfusion Cannula is a vascular cannula intended for perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction. It is classified as a Class II medical device under the product code DWF for catheter, cannula and tubing, vascular, cardiopulmonary bypass.

The device is supplied by Chase Medical, Inc. and is intended for use in cardiovascular procedures. It received FDA 510(k) clearance with the number K964199 on March 19, 1997, as substantially equivalent under regulation 870.4210. The device is manufactured in Richardson, Texas.

Frequently asked questions

What is the Chase Coronary Sinus Perfusion Cannula used for?

The Chase Coronary Sinus Perfusion Cannula is designed for perfusing cardioplegia solutions retrograde through the coronary sinus via transatrial introduction during cardiovascular procedures.

How is the Chase Coronary Sinus Perfusion Cannula supplied?

The device is supplied by Chase Medical, Inc., which is located in Richardson, Texas, and is manufactured there as well.

What is the regulatory classification of the Chase Coronary Sinus Perfusion Cannula?

The device is classified as a Class II medical device under product code DWF for catheter, cannula and tubing, vascular, cardiopulmonary bypass.

What is the FDA clearance status of the Chase Coronary Sinus Perfusion Cannula?

The device received FDA 510(k) clearance with number K964199 on March 19, 1997, as substantially equivalent under regulation 870.4210.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CHASE CORONARY SINUS PERFUSION CANNULA - Innolitics, PDF K964199 - Chase Coronary Sinus Perfusion Cannula, CHASE CORONARY SINUS PERFUSION CANNULA 510(k) K964199 - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Chase Medical, Inc.

Sources (1)

  • FDA 510(k) K964199 24 fields · synced Sep 19, 2026