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AngioDynamics, Inc. Morpheus CT PICC and Procedure Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K070613

by Angiodynamics, Inc.

Identifiers

510(k) Number
K070613 FDA 510(k)
FDA Product Code
LJS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5970 FDA 510(k)
Regulation Number
880.5970 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Morpheus CT PICC and Procedure Kit is a catheter for intravascular therapeutic use, designed for short or long term peripheral access to the central venous system. It is intended for intravenous therapy, power injections of contrast media, and allows for central venous pressure monitoring. The device is available in various sizes, with a 4 French or larger catheter recommended for blood sampling, infusion, or therapy use.

The kit is supplied by AngioDynamics, Inc. and has received FDA 510(k) clearance with the product code LJS. It is classified as a Class II device for therapeutic use greater than 30 days. The device is intended for use in general hospital settings and is regulated under 880.5970.

Frequently asked questions

What is the Morpheus CT PICC and Procedure Kit used for?

The Morpheus CT PICC and Procedure Kit is a catheter designed for intravascular therapeutic use, providing short or long term peripheral access to the central venous system. It is intended for intravenous therapy, power injections of contrast media, and allows for central venous pressure monitoring.

What sizes are available for the Morpheus CT PICC and Procedure Kit?

The device is available in various sizes, with a 4 French or larger catheter recommended for blood sampling, infusion, or therapy use. The specific size options are not detailed in the provided information.

What is the regulatory status of the Morpheus CT PICC and Procedure Kit?

The Morpheus CT PICC and Procedure Kit has received FDA 510(k) clearance with the product code LJS. It is classified as a Class II device for therapeutic use greater than 30 days and is regulated under 880.5970.

How is the Morpheus CT PICC and Procedure Kit supplied?

The kit is supplied by AngioDynamics, Inc. as a complete procedure kit containing the necessary components for the insertion and use of the PICC catheter. The specific contents of the kit are not detailed in the provided information.

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: Angiodynamics, Inc Morpheus Picc and Procedure Kit (K072196) — Fda 510 ..., Angiodynamics, Inc., Morpheus Ct Picc and Procedure Kit, ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT by ANGIODYNAMICS ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Angiodynamics, Inc.

Sources (1)

  • FDA 510(k) K070613 24 fields · synced Oct 1, 2026