Itc Catheters W Hydromer
Interventional Therapeutics
FDA Clearance Information
The ITC Catheters with Hydromer were cleared through the FDA 510(k) pathway on April 30, 1993. Manufactured by Interventional Therapeutics, this device is classified as Class 2 under product code DQY.
What It Is
FDA-Cleared Indications
- Use as a percutaneous catheter within the vascular system, consistent with the device's FDA classification and labeling.
- The available FDA record does not state a complete, procedure-specific indication for venous stenting.
Clinical Applications
- Percutaneous catheterization of blood vessels during endovascular procedures.
- Navigation through venous anatomy when the catheter's labeled size and configuration are appropriate.
- Catheter-based access and delivery during procedures performed under fluoroscopic or other intravascular imaging guidance.
Reported off-label uses
- Use as an adjunct catheter during venous stent delivery or positioning when consistent with institutional practice and the device's physical specifications.
- Use during catheter-based treatment of venous obstruction, including selected iliac or central venous interventions, when the device is not specifically labeled for that application.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- Confirm the current package insert for available catheter sizes, length, lumen dimensions, guidewire compatibility, and maximum recommended pressure before use.
- Hydrophilic coatings require appropriate wetting and handling according to the manufacturer's instructions; avoid damaging the coating during insertion or advancement.
- Use fluoroscopy or another suitable imaging method and advance the catheter gently. Do not force the device against resistance.
- The supplied FDA record does not establish MRI safety. MRI status should be verified in the current labeling before scanning a patient with the catheter in place.
- Contraindications, warnings, and compatibility with stents, guidewires, contrast agents, and introducer sheaths should be checked in the current manufacturer instructions.
Procedures that use this device
Frequently Asked Questions
What is ITC Catheters with Hydromer used for?
They are used for facilitating venous stenting procedures, helping in the placement of stents in veins.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures, particularly for patients with conditions requiring stent placement in veins.