Anteplegia Antegrade Cardioplegia Catheter Aortic Root Cannula With Duraflo Coating
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K113459 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)
The Anteplegia catheter is a cardiopulmonary bypass vascular cannula and tubing device. It is designed to cannulate vessels and perfuse the coronary arteries during cardiopulmonary surgery.
This device is used to interconnect catheters and cannulas with an oxygenator. It is authorized for use under FDA 510(k) clearance.
Frequently asked questions
What is the primary function of the Anteplegia catheter?
The Anteplegia catheter is a vascular cannula and tubing device used during cardiopulmonary surgery. Its primary purpose is to cannulate vessels and facilitate the perfusion of coronary arteries.
How does this device integrate into a surgical circuit?
This device is designed to serve as an interface, allowing for the interconnection of catheters and cannulas with an oxygenator during cardiopulmonary bypass procedures.
What is the regulatory status of this device?
The Anteplegia catheter is authorized for use under FDA 510(k) clearance, which indicates that it has been found substantially equivalent to legally marketed predicate devices.
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: Anteplegia Catheter Antegrade Cardioplegia Catheter Aortic Root Cannula ..., Anteplegia Catheter Antegrade Cardioplegia Catheter Aortic Root Cannula ..., Antegrade Aortic Root Cardioplegia Cannula | LivaNova US, Adult Cardioplegia Circuit - Overview | Medtronic
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113459 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA 510(k) K113459 24 fields · synced Sep 22, 2026