PleurX catheters
Faller Stylet
by Medionics International Inc
A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.
Where to buy Faller Stylet
We do not have contact details for Medionics International Inc yet. Send a request and we will route it to the right person for your country.
Faller Stylet models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| FS-401 | — | Not stated | Available |
| FS-402 | — | Not stated | Available |
| FS-403 | — | Not stated | Available |
| FS-404 | — | Not stated | Available |
FDA clearances
- 510(k) K130441 April 2013
Procedures that use pleurx catheters
Frequently asked questions
What is Faller Stylet used for?
A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.
Who makes Faller Stylet?
Faller Stylet is made by Medionics International Inc. It is listed under tunneled pleural and peritoneal catheters (pleurx) in our device library.
What sizes does Faller Stylet come in?
The FDA device database does not list sizes for Faller Stylet. Check the instructions for use or ask a Medionics International Inc representative.
Is Faller Stylet MRI safe?
The FDA device database entry for Faller Stylet does not state its MRI safety status. Check the labeling before MRI.
Is Faller Stylet FDA cleared?
Faller Stylet is covered by FDA submission K130441.
How do I contact a Medionics International Inc sales representative?
Medionics International Inc has not listed representatives on LA Vascular yet. Visit the Medionics International Inc company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.