← Product Code [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF) · K964393 # CHASE RETROGRADE CARDIOPLEGIA CANNULA (K964393) _Chase Medical, Inc. · DWF · Apr 23, 1997 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K964393 ## Device Facts - **Applicant:** Chase Medical, Inc. - **Product Code:** [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF.md) - **Decision Date:** Apr 23, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.4210 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Indications for Use The Chase Retrograde Cardioplegia Cannula is intended for use in perfusing blood or cardioplegia solutions via the coronary sinus during cardiopulmonary bypass surgery. ## Device Story Dual lumen 14 FR cannula; used during cardiopulmonary bypass surgery. Primary lumen infuses blood/cardioplegia; secondary lumen monitors pressure via stopcock/female luer lock. Distal tip features soft, low-pressure balloon; inflates automatically via differential infusion pressures; deflates spontaneously upon flow cessation. Includes stylet for transatrial placement in coronary sinus. Operated by surgical team in OR. Provides localized cardioplegia delivery to heart muscle; facilitates myocardial protection during bypass. ## Clinical Evidence Bench testing only. No clinical data provided. Testing included leak testing at 10 psi (4°C and 40°C), tubing bond strength (>10 lb tensile), luer connection compliance (ANSI/HIMA MD70.1-1983), package integrity (ASTM F1140-88), and shipping/distribution vibration/drop tests. ## Technological Characteristics 14 FR dual-lumen cannula; materials identical to predicate. Features distal low-pressure balloon, pressure monitoring lumen, and stylet. Luer connections meet ANSI/HIMA MD70.1-1983. Sterilization via 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 - Research Medical Retrograde Cardioplegia Cannula ([K880103](/device/K880103.md)) ## 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} K964393 APR 23 1997 # SUMMARY OF SAFETY AND EFFECTIVENESS ## CHASE RETROGRADE CARDIOPLEGIA CANNULA ### I. General Information A. Generic Name: Retrograde Cardioplegia Cannula B. Trade Name of Device: CHASE Retrograde Cardioplegia Cannula C. Applicant's Name and Address: CHASE Medical Inc. 1876 Firman Drive. Richardson, Texas 75081 D. Pre-market Notification Number: Not yet assigned ### II. Indications for Use The Chase Retrograde Cardioplegia Cannula is intended for use in perfusing blood or cardioplegia solutions via the coronary sinus during cardiopulmonary bypass surgery. ### III. Device Description The Chase Retrograde Cardioplegia Cannula is a dual lumen 14 FR cannula. The cannula body contains a primary lumen for infusing blood or cardioplegia solutions and a secondary pressure monitoring lumen that begins at the cannula's tip and terminates in a stopcock with a female luer lock. During infusions, differential pressures occurring within the cannula automatically inflate a soft, low pressure balloon located near the cannula's distal tip. When flow ceases, the balloon spontaneously deflates. A stylet is also provided to aid transatrial cannula placement within the coronary sinus. ### IV. Device Classification: Class II ### V. Safety and Effectiveness Substantial Equivalence: The device is substantially equivalent to the Research Medical Retrograde Cardioplegia Cannula (K880103). ### 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 {1} # SUMMARY OF SAFETY AND EFFECTIVENESS ## Functional Testing All functional characteristics of the Chase Retrograde Cardioplegia Cannula are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition. Leak Test Requirements: No leaks at 10 psi air on CHASE device at 4°C and 40°C Tubing Bond Strength: Exceeds 10 lb. tensile strength @ 4°C and 40°C 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K964393](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K964393) **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. 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