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Quest Antegrade Cardioplegia Cannula

FDA 510(k)

Class II (US FDA 510(k))

510(k) K950814

by Quest Medical Inc

Identifiers

510(k) Number
K950814 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 Antegrade Cardioplegia Cannula is a vascular catheter designed for cardiopulmonary bypass procedures. It delivers cardioplegic solution directly to the coronary arteries to induce myocardial protection during cardiac surgery, ensuring temporary cessation of the heart’s beating for precise surgical intervention.

This single-use device is intended for sterile use in operating room settings and is classified as a Class II medical device under FDA regulations (DWF product code). It is supplied in a sterile, disposable package and must be handled according to standard surgical aseptic techniques. The device holds an FDA 510(k) clearance (K950814) under the Traditional pathway, with a decision date of May 25, 1995.

Frequently asked questions

What is the primary purpose of the Quest Antegrade Cardioplegia Cannula in cardiac surgery?

The Quest Antegrade Cardioplegia Cannula is designed to deliver cardioplegic solution directly into the coronary arteries during cardiopulmonary bypass procedures. This ensures temporary myocardial protection by inducing a controlled cessation of the heart’s beating, allowing surgeons to perform precise interventions safely.

Is the Quest Antegrade Cardioplegia Cannula reusable, or is it intended for single-use only?

The device is explicitly labeled as a single-use item, intended for sterile use in operating room settings only. It must be handled according to standard surgical aseptic techniques to maintain sterility and prevent contamination.

How is the Quest Antegrade Cardioplegia Cannula supplied, and what precautions should be taken during handling?

The cannula is supplied in a sterile, disposable package, ensuring it is ready for immediate use in the OR. Since it is single-use, it must be opened and handled using strict aseptic techniques to avoid cross-contamination, adhering to standard surgical protocols.

What regulatory pathway was followed for FDA clearance of this device, and when was it approved?

The Quest Antegrade Cardioplegia Cannula received FDA clearance under the Traditional 510(k) pathway as substantially equivalent to a predicate device. The clearance (K950814) was issued on May 25, 1995, by the FDA’s Cardiovascular (CV) Advisory Committee.

Are there multiple sizes or models available for the Quest Antegrade Cardioplegia Cannula, or is it a single standardized design?

The provided data does not specify individual sizes or models, but the device is categorized under vascular catheters for cardiopulmonary bypass with multiple OpenFDA registration numbers, suggesting potential variations in design or sizing. For exact sizing details, refer to the manufacturer’s product documentation or catalog.

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 ANTEGRADE CARDIOPLEGIA CANNULA (K950814) — FDA 510 (k) | Innolitics, Quest Antegrade Cardioplegia Cannula 510 (k) FDA Premarket Notification ..., PDF K950814 - Quest Antegrade Cardioplegia Cannula, fda.innolitics.com, Myocardial Protection Systems | Nordson MEDICAL

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Quest Medical Inc
FDA Applicant
Quest Medical, Inc.

Sources (1)

  • FDA 510(k) K950814 24 fields · synced Sep 19, 2026