Identifiers
- 510(k) Number
- K200499 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 QuickDraw Venous Cannula is a catheter, cannula and tubing, vascular, cardiopulmonary bypass device intended to drain non-oxygenated blood from the venae cavae or right atrium during cardiopulmonary bypass. It is supplied sterile and non-pyrogenic in a sealed, peel-type pouch.
The device is a single-use product packaged for clinical use in cardiovascular procedures. It received FDA 510(k) clearance (K200499) on March 29, 2020, under regulation number 870.4210, with product code DWF and classification as a Class II device.
Frequently asked questions
What is the QuickDraw Venous Cannula used for?
The QuickDraw Venous Cannula is intended to drain non-oxygenated blood from the venae cavae or right atrium during cardiopulmonary bypass procedures, as specified in its device description for vascular cardiopulmonary bypass use.
How is the QuickDraw Venous Cannula supplied and is it sterile?
The device is supplied sterile and non-pyrogenic in a sealed, peel-type pouch, ensuring it is ready for clinical use without additional sterilization prior to application in cardiovascular procedures.
Is the QuickDraw Venous Cannula designed for single-use or reuse?
The QuickDraw Venous Cannula is a single-use product packaged for clinical use in cardiovascular procedures, meaning it is intended for one patient and one procedure only, then discarded.
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: International Medical Devices Database, QuickDraw Venous Cannula (K200499) — FDA 510 (k) | Innolitics, QuickDraw Venous Cannula 510 (k) K200499 - FDA.report, QuickDraw Venous Cannula by Edwards Lifesciences LLC | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200499 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA 510(k) K200499 24 fields · synced Oct 1, 2026