Who is the manufacturer of CHASE CORONARY OSTIAL PERFUSION CANNULA?

Chase Medical, Inc. filed the 510(k) submission for CHASE CORONARY OSTIAL PERFUSION CANNULA (K971041).

What is the FDA product code for CHASE CORONARY OSTIAL PERFUSION CANNULA?

DWF. It is classified under 21 CFR 870.4210 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CHASE CORONARY OSTIAL PERFUSION CANNULA?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CHASE CORONARY OSTIAL PERFUSION CANNULA?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CHASE CORONARY OSTIAL PERFUSION CANNULA

K971041 · Chase Medical, Inc. · DWF · May 13, 1997 · Cardiovascular

Device Facts

Record ID	K971041
Device Name	CHASE CORONARY OSTIAL PERFUSION CANNULA
Applicant	Chase Medical, Inc.
Product Code	DWF · Cardiovascular
Decision Date	May 13, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4210
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring direct delivery of cardioplegia solutions to the coronary arteries.

Regulatory Classification

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

Related Devices

K131269 — DLP CORONARY OSTIAL PERFUSION CANNULAE · Medtronic, Inc. · Jul 10, 2013
K034058 — SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011 · Medtronic Vascular · Jan 29, 2004
K162500 — Ostial Sprit Cannulae · Spyder Medical · Jan 12, 2017
K240193 — R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) · Sorin Group Italia S.R.L. · Feb 22, 2024
K964200 — CHASE MULTIPLE PERFUSION SET · Chase Medical, Inc. · Apr 16, 1997

Submission Summary (Full Text)

{0} 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. {1} # 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 |