Identifiers
- 510(k) Number
- K191107 FDA 510(k)
- FDA Product Code
- JOW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5800 FDA 510(k)
- Regulation Number
- 870.5800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Plexus is a sleeve, limb, compressible device designed for cardiovascular applications. It is manufactured by Alleva Medical (D.G), Ltd. and has received FDA 510(k) clearance with the product code JOW.
The Plexus is supplied in various sizes as indicated by the multiple registration numbers. It is a Class II medical device regulated under 870.5800. The device is not specified as single-use or reusable, and no information regarding sterility or MRI safety is provided in the data.
Frequently asked questions
What is the Plexus device used for?
The Plexus is a sleeve, limb, compressible device specifically designed for cardiovascular applications. It is manufactured by Alleva Medical (D.G), Ltd. and has received FDA 510(k) clearance with product code JOW.
How is the Plexus device supplied?
The Plexus is supplied in various sizes as indicated by the multiple registration numbers. It is a Class II medical device regulated under 870.5800. The device is not specified as single-use or reusable in the provided data.
What is the regulatory status of the Plexus device?
The Plexus has received FDA 510(k) clearance with the product code JOW. It is classified as a Class II medical device under regulation number 870.5800. The device was reviewed by the Cardiovascular advisory committee and determined to be substantially equivalent.
Is the Plexus device sterile and MRI safe?
No information regarding sterility or MRI safety is provided in the device data. The description does not specify whether the device is supplied sterile or if it is safe for use in MRI environments.
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 | K191107 | Class II | Active |
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Manufacturer
- Manufacturer
- Alleva Medical (D.G), Ltd.
Sources (1)
- FDA 510(k) K191107 24 fields · synced Sep 21, 2026