CHASE CURVED LEFT HEART VENT CATHETER
Device Facts
| Record ID | K964194 |
|---|---|
| Device Name | CHASE CURVED LEFT HEART VENT CATHETER |
| Applicant | Chase Medical, Inc. |
| Product Code | DWF · Cardiovascular |
| Decision Date | Apr 16, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4210 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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.
Indications for Use
Indicated for patients undergoing cardiopulmonary bypass requiring left heart venting via the right superior pulmonary vein and mitral valve.
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
- Sarns Curved Left Heart Vent Catheter (K770430)
Related Devices
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- K981601 — CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER · Sorin Group Italia S.R.L. · Jul 28, 1998
- K012143 — 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 · Medtronic Cardiac Surgical Products · Oct 24, 2001
- K113411 — EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA · Edwards Lifesciences, LLC · Jun 11, 2012
