← Product Code [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF) · K964194 # CHASE CURVED LEFT HEART VENT CATHETER (K964194) _Chase Medical, Inc. · DWF · Apr 16, 1997 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K964194 ## Device Facts - **Applicant:** Chase Medical, Inc. - **Product Code:** [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF.md) - **Decision Date:** Apr 16, 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 Curved Left Heart Vent Catheter is indicated for use in venting the left heart during cardiopulmonary bypass with entrance made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve. ## Device Story Device is a 20 French preformed, flexible plastic vent catheter; features perforated section and tapered rigid tip for insertion; includes rigid connector for 6.4mm I.D. tubing; depth marking rings provided. Used by surgeons during cardiopulmonary bypass procedures to vent the left heart. Device facilitates drainage of blood from the left atrium/ventricle to maintain a bloodless field and prevent distension. Operation involves manual insertion through the right superior pulmonary vein and mitral valve. Benefits include effective decompression of the left heart during bypass. ## Clinical Evidence Bench testing only. Testing included leak testing (no leaks at 10 psi at 4°C and 40°C), tubing bond strength (>10 lb tensile strength at 4°C and 40°C), package integrity (Tyvek/Polymylar burst test per ASTM F1140-88), shipping/distribution vibration/drop tests, and accelerated aging (two-year shelf life). ## Technological Characteristics 20 French preformed flexible plastic tube; rigid plastic tapered tip; rigid plastic tube connector for 6.4mm I.D. tubing; depth marking rings. Sterilization: 100% Ethylene Oxide (Overkill Method, SAL 10⁻⁶). Packaging: Tyvek/Polymylar per ASTM F1140-88. ## 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 - Sarns Curved Left Heart Vent Catheter ([K770430](/device/K770430.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} KR24194 APR 16 1997 # SUMMARY OF SAFETY AND EFFECTIVENESS ## CHASE CURVED LEFT HEART VENT CATHETER ### I. General Information A. Generic Name: Curved Left Heart Vent Catheter B. Trade Name of Device: CHASE CURVED LEFT HEART VENT CATHETER C. Applicant’s Name and Address: CHASE MEDICAL INC., Richardson, TX D. Pre-market Notification Number: Not assigned ### II. Indication for Use: The CHASE Curved Left Heart Vent Catheter is indicated for use in venting the left heart during cardiopulmonary bypass with entrance made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve. ### III. Device Description The vent catheter consists of a preformed, flexible plastic tube, (20 French), with a perforated section. A small tapered tip of rigid plastic is attached to the perforated section to aid in the insertion of the catheter. A rigid plastic tube connector for 6.4mm (1/4”) I.D. tubing is permanently attached to the other end of the catheter tube. Marking rings on the tube serve as an indication of insertion depth. ### IV. Device Classification: Class II device ### V. Safety and Effectiveness: Substantial Equivalence: This device is substantially equivalent to the Sarns Curved Left Heart Vent Catheter K770430. ### 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 Medical Curved Left Heart Vent Catheter are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition. {1} # SUMMARY OF SAFETY AND EFFECTIVENESS | 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 | | 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/K964194](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K964194) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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