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Medtronic DLP Arterial Cannulae

FDA 510(k)

Class II (US FDA 510(k))

510(k) K991066

by Medtronic Vascular

Identifiers

510(k) Number
K991066 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 Medtronic DLP Arterial Cannulae are vascular cannulas designed for use in cardiopulmonary bypass procedures. These devices facilitate the establishment of arterial access, enabling controlled blood flow during extracorporeal circulation by connecting the patient’s arterial system to the bypass circuit.

Supplied as single-use devices to minimize cross-contamination, these cannulae are available in various sizes and configurations, including blunt-tipped and curved-tip variants. They are intended for sterile use in operating room settings and comply with FDA 510(k) clearance under the traditional pathway. The devices are classified as Class II medical devices and are regulated under the U.S. regulation number 870.4210.

Frequently asked questions

What types of procedures are the Medtronic DLP Arterial Cannulae specifically designed for?

The Medtronic DLP Arterial Cannulae are designed exclusively for cardiopulmonary bypass procedures. They provide arterial access to connect a patient’s arterial system to the extracorporeal circulation circuit, ensuring controlled blood flow during surgery.

Are these cannulae reusable or intended for single-use only?

These cannulae are supplied as single-use devices to minimize the risk of cross-contamination between patients. This aligns with best practices for sterile operating room procedures.

What variations in size and tip design are available for the Medtronic DLP Arterial Cannulae?

The cannulae come in multiple sizes and configurations, including blunt-tipped and curved-tip variants. This variety allows for flexibility in accessing different arterial sites during cardiopulmonary bypass procedures.

How should the Medtronic DLP Arterial Cannulae be stored before use?

Since these are sterile, single-use devices, they should be stored in their original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Proper storage ensures sterility and device integrity until use.

What regulatory pathway was followed for FDA clearance of these cannulae?

The Medtronic DLP Arterial Cannulae were cleared through the FDA’s traditional 510(k) pathway, with a decision dated September 14, 1999. They are classified as Class II medical devices under regulation number 870.4210 and were reviewed by the Cardiovascular (CV) Advisory Committee.

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: Cardiovascular Cannulae | Medtronic, DLP Vessel Cannulae - Medline, Medtronic DLP Vessel Cannulae - CANNULA, VESSEL, RAD, BLUNT, 3MM - 300 ..., Medtronic Usa DLP Curved-Tip Arterial Cannula - DPL81022H

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K991066 24 fields · synced Oct 6, 2026