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Selectra Accessory Kit Selectra Slitter Tool
Summary: The Selectra Accessory Kit, including the Selectra Slitter Tool, is used in venous stenting procedures. It is primarily utilized by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K131978 ↗
Decision Date ?
August 23, 2013
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Selectra Accessory Kit by Biotronik was cleared through the FDA 510(k) pathway on August 23, 2013. It is classified as a Class 2 device under product code DQY.
What It Is
The Selectra Accessory Kit, featuring the Selectra Slitter Tool, is designed to assist in the placement and deployment of venous stents. The tool helps in creating a precise slit in the sheath, facilitating the smooth passage and positioning of stents within the venous system. This device is particularly useful in complex stenting procedures where precision and control are paramount.
FDA-Cleared Indications
- Used as an accessory during percutaneous venous stent placement procedures.
- Used to slit or remove a vascular sheath to facilitate deployment of a venous stent.
- Classified by the FDA under product code DQY, catheter, percutaneous, under 21 CFR 870.1250.
Clinical Applications
- Percutaneous placement and deployment of venous stents.
- Sheath slitting during venous stenting procedures.
- Venous stenting for appropriately selected venous obstruction or narrowing when a percutaneous stent procedure is indicated.
- Use during iliac or central venous stent procedures when the delivery sheath must be removed without disturbing the stent.
Practical Considerations
- Confirm compatibility with the specific Selectra system, vascular sheath, stent delivery system, and stent size before the procedure.
- The slitter is intended for controlled sheath handling; it should be used only by clinicians trained in the associated technique.
- Device dimensions, sheath compatibility, and procedural instructions should be verified in the current manufacturer’s instructions for use.
- MRI safety depends on the specific device configuration and whether any component remains in the patient; consult the current labeling before MRI.
- Contraindications, warnings, and precautions should be reviewed in the current FDA-cleared labeling. The kit is not a treatment for venous disease by itself.
Procedures that use this device
Frequently Asked Questions
What is the Selectra Accessory Kit used for?
It is used for assisting in the placement and deployment of venous stents during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in venous stenting procedures, particularly for patients with venous obstructions or structural abnormalities.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.