Shelly Protected AV Fistula Needle
FDA 510(k)Class II (US FDA 510(k))
by Diasol, Inc.
Identifiers
- 510(k) Number
- K993187 FDA 510(k)
- FDA Product Code
- FPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Shelly Protected AV Fistula Needle is a specialized needle designed for accessing arteriovenous (AV) fistulas, which are surgically created connections between an artery and a vein. This device is essential for hemodialysis, allowing for efficient blood flow from the patient to the dialysis machine. The 'protected' aspect likely refers to safety features that minimize needle-stick injuries.
The device is supplied by Diasol, Inc. and has received FDA 510(k) clearance with product code FPA. It is intended for use in hospital settings and is classified under General Hospital advisory committee. The device is available in various sizes and models, though specific details are not provided in the data.
Frequently asked questions
What is the Shelly Protected AV Fistula Needle used for?
The Shelly Protected AV Fistula Needle is designed for accessing arteriovenous (AV) fistulas, which are surgically created connections between an artery and a vein. It is essential for hemodialysis procedures, allowing efficient blood flow from the patient to the dialysis machine.
What safety features does the Shelly Protected AV Fistula Needle have?
The 'protected' aspect of this needle refers to safety features that are specifically designed to minimize needle-stick injuries during use. These features help protect healthcare professionals from accidental needle punctures while performing hemodialysis procedures.
What sizes and models of the Shelly Protected AV Fistula Needle are available?
The device is available in various sizes and models, though specific details about the exact measurements or model variations are not provided in the available data. The manufacturer, Diasol, Inc., would be able to provide more detailed information about the specific options available.
Is the Shelly Protected AV Fistula Needle single-use or reusable?
The device data does not specify whether the Shelly Protected AV Fistula Needle is designed for single-use or multiple uses. This information would typically be included in the product's instructions for use, which should be consulted for proper handling and disposal procedures.
What is the regulatory status of the Shelly Protected AV Fistula Needle?
The Shelly Protected AV Fistula Needle has received FDA 510(k) clearance with product code FPA. It was classified under the General Hospital advisory committee and received a decision code of SESE (Substantially Equivalent) on November 5, 1999.
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: K992653 FDA 510 (k) - SHELLY PROTECTED AV FISTULA NEEDLE, Shelly Protected AV Fistula Needle - Diasol | FDA Reference, K993187 FDA 510 (k) - SHELLY PROTECTED AV FISTULA NEEDLE
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993187 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasol, Inc.
Sources (1)
- FDA 510(k) K993187 24 fields · synced Sep 28, 2026