Cardioplegia Delivery Sets With Duraflo Coating
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K113667 FDA 510(k)
- FDA Product Code
- DTL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4290 FDA 510(k)
- Regulation Number
- 870.4290 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Cardioplegia delivery sets are extracorporeal circuit components consisting of clear manifold connections (straight, Y-shaped, or 4-way) and flexible tubing. They are intended for use as adapters for connecting cardioplegia administration tubing to cardioplegia delivery catheters.
These sets are supplied with a Duraflo coating and are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. The device is classified as a Class II medical device under FDA regulation number 870.4290 and has received FDA 510(k) clearance (K113667).
Frequently asked questions
What is the intended use of the Cardioplegia Delivery Sets with Duraflo Coating?
These sets are intended for use as adapters to connect cardioplegia administration tubing to cardioplegia delivery catheters during cardiopulmonary surgery when a heparin-coated blood path is desired.
How are the Cardioplegia Delivery Sets with Duraflo Coating supplied?
The device is supplied with a Duraflo coating on clear manifold connections (straight, Y-shaped, or 4-way) and flexible tubing components of the extracorporeal circuit.
Is the Cardioplegia Delivery Set with Duraflo Coating intended for single-use or reuse?
The device description does not specify single-use or reuse; however, as an extracorporeal circuit component with a coating intended for heparin-coated blood paths, it is typically designed for single-use to maintain sterility and coating integrity.
What regulatory pathway was used for the Cardioplegia Delivery Sets with Duraflo Coating?
The device received FDA 510(k) clearance under submission K113667 and is classified as a Class II medical device under regulation 870.4290.
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: Cardioplegia Delivery Sets Cardioplegia Delivery Sets With Duraflo ..., fda.innolitics.com, Global Myocardial Protection - Edwards Lifesciences - PDF Catalogs ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113667 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA 510(k) K113667 24 fields · synced Sep 27, 2026