Quest Retrograde Cardiplegia Cannula-RCCS
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K951088 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 Quest Retrograde Cardiplegia Cannula-RCCS is a vascular cannula designed for cardiopulmonary bypass procedures. It facilitates retrograde infusion of cardioplegic solutions to induce temporary cardiac arrest during surgical interventions, ensuring myocardial protection.
This device is intended for single-use in controlled clinical settings such as operating rooms. It is classified as a Class II medical device under FDA regulations (DWF product code) and has received FDA 510(k) clearance (K951088) as substantially equivalent to a predicate device. The cannula is supplied sterile and must be handled according to aseptic techniques to maintain sterility before use.
Frequently asked questions
What is the primary clinical purpose of the Quest Retrograde Cardiplegia Cannula-RCCS during surgery?
The Quest Retrograde Cardiplegia Cannula-RCCS is specifically designed for cardiopulmonary bypass procedures to deliver cardioplegic solutions retrograde through the coronary sinus. This infusion induces temporary cardiac arrest, protecting the heart muscle (myocardium) during surgical interventions by ensuring adequate perfusion and oxygenation while the heart is stopped.
Is the Quest Retrograde Cardiplegia Cannula-RCCS intended for reuse in clinical settings, or is it single-use only?
The device is explicitly intended for single-use in controlled clinical settings like operating rooms. It is supplied sterile and must be handled using aseptic techniques to preserve sterility before use, as reuse is not recommended or supported by its design.
How is the Quest Retrograde Cardiplegia Cannula-RCCS packaged and stored to maintain its integrity?
The cannula is supplied sterile in its original packaging, which must be preserved until use. Proper storage involves keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain unopened and intact until immediately before use to ensure sterility and functionality.
Are there different sizes or models available for the Quest Retrograde Cardiplegia Cannula-RCCS, and how would I determine the correct fit for a patient?
The device data does not specify exact sizes or model variations, but the cannula is designed for retrograde infusion during cardiopulmonary bypass, implying compatibility with standard coronary sinus cannulation techniques. Selection should be based on clinical judgment, patient anatomy, and the specific surgical requirements. Consulting the manufacturer’s instructions or a surgical specialist is recommended for precise sizing.
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: QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS (K951088) — FDA 510(k ..., Quest Retrograde Cardiplegia Cannula-rccs - Beudamed, PDF K951088 - Quest Retrograde Cardiplegia Cannula-rccs, fda.innolitics.com, QUEST MEDICAL, 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 | K951088 | Class II | Active |
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Manufacturer
- Manufacturer
- Quest Medical Inc
- FDA Applicant
- Quest Medical, Inc.
Sources (1)
- FDA 510(k) K951088 24 fields · synced Sep 19, 2026