Tubing for Cardiopulmonary Bypass
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K833112 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)
This device is a Catheter, Cannula and Tubing for Cardiopulmonary Bypass, designed to facilitate the circulation of blood during cardiopulmonary bypass procedures. It provides a conduit for oxygenated blood to be delivered from the oxygenator to the patient while venous blood is returned to the oxygenator, ensuring continuous perfusion during open-heart surgeries or other cardiac interventions.
The tubing is supplied as a single-use medical device and is intended for use in controlled clinical environments such as operating rooms or cardiac catheterization labs. It is regulated under FDA 510(k) clearance (K833112) and classified as a Class II device (regulation number 870.4210). Multiple sizes and reference codes are available, as listed in the product specifications, ensuring compatibility with various cardiopulmonary bypass systems. Sterility and proper storage conditions are critical for maintaining device integrity prior to use.
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: TUBING FOR CARDIOPULMONARY BYPASS (K833112) — FDA 510(k) | Innolitics, Cardio Med Supplies Inc FDA Filings, Cardiomed Supplies Inc - RevMed, Cardiomed-Supplies-Inc FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K833112 | Class II | Active |
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Manufacturer
- Manufacturer
- Cardio Med Supplies, Inc.
Sources (1)
- FDA 510(k) K833112 24 fields · synced Sep 19, 2026