AngioDynamics, Inc Morpheus PICC and Procedure Kit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K072196 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)
This device is a catheter, intravascular, therapeutic, long-term greater than 30 days, as defined by its device type and nomenclature. It is supplied as a kit that includes the Morpheus PICC and associated procedural components for vascular access.
The kit is intended for use in general hospital settings and is supplied non-sterile or sterile as per the manufacturer's specifications. It is a single-use device, and its regulatory status is based on FDA 510(k) clearance under K072196, with product code LJS and regulation number 880.5970.
Frequently asked questions
What is the Morpheus PICC and Procedure Kit used for?
The kit is intended for vascular access in general hospital settings, providing a long-term intravascular catheter designed for use greater than 30 days as part of therapeutic procedures.
How is the Morpheus PICC and Procedure Kit supplied, and is it sterile?
The kit is supplied either sterile or non-sterile according to the manufacturer's specifications, allowing flexibility based on clinical setting and procedural requirements.
Is the Morpheus PICC and Procedure Kit reusable or single-use?
The device is designated as a single-use device, meaning it is intended for one patient and one procedure only, and should not be reprocessed or reused.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072196 | Class II | Active |
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Manufacturer
- Manufacturer
- Angiodynamics, Inc.
Sources (1)
- FDA 510(k) K072196 24 fields · synced Sep 23, 2026