Attain Prevail Left Heart Delivery System Moddel, 6228sys
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K032622 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Attain Prevail Left Heart Delivery System is a medical device that provides a pathway for transvenous device delivery to the coronary sinus and coronary vasculature. It includes a steerable catheter, straight guide catheters (45cm/50cm), stainless steel guide wires (0.016"/0.035"), 3-way stopcock, universal slitter, introducer valve, guide catheter dilator, Y-connector with hemostasis valve, and torque tools.
The system is manufactured by Medtronic Vascular and was cleared by the FDA via the 510(k) pathway on September 3, 2003. It is a Class 2 device under product code DQY. The device is supplied as a complete system for use in transvenous delivery procedures.
Frequently asked questions
What is the purpose of the Attain Prevail Left Heart Delivery System?
The Attain Prevail Left Heart Delivery System provides a pathway for transvenous device delivery to the coronary sinus and coronary vasculature, facilitating various cardiac procedures.
What components are included in the Attain Prevail Left Heart Delivery System?
The system includes a steerable catheter, straight guide catheters (45cm/50cm), stainless steel guide wires (0.016'/0.035'), 3-way stopcock, universal slitter, introducer valve, guide catheter dilator, Y-connector with hemostasis valve, and torque tools.
Is the Attain Prevail Left Heart Delivery System single-use or reusable?
The device is supplied as a complete system for use in transvenous delivery procedures, but the description does not specify whether it is single-use or reusable.
What is the regulatory status of the Attain Prevail Left Heart Delivery System?
The device was cleared by the FDA via the 510(k) pathway on September 3, 2003, and is classified as a Class 2 device under product code DQY.
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: Attain Prevail Left Heart Delivery System Moddel, 6228sys, attain prevail left heart delivery system moddel 6228sys, Attain Prevail Left Heart Delivery System Moddel 6228sys
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032622 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K032622 24 fields · synced Oct 6, 2026