đź“‹ FDA Reference
The Crosser 14 OTW Catheter Model CRU014
Flowcardia
Summary: The Crosser 14 OTW Catheter by Flowcardia is a medical device used for crossing chronic total occlusions in peripheral arteries. It is typically used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K091254 ↗
Decision Date ?
May 29, 2009
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Crosser 14 OTW Catheter was cleared through the FDA 510(k) pathway on May 29, 2009. Manufactured by Flowcardia, it is a Class 2 device under product code DQY.
What It Is
The Crosser 14 OTW Catheter is designed to facilitate the crossing of chronic total occlusions in peripheral arteries. It operates by using high-frequency mechanical vibrations to penetrate tough occlusions. This device is particularly useful in cases where traditional guidewire techniques are unsuccessful, providing an alternative method for revascularization.
FDA-Cleared Indications
- Used to facilitate crossing chronic total occlusions in peripheral arteries.
- Intended for use during endovascular procedures to facilitate treatment of peripheral arterial occlusions.
Clinical Applications
- Crossing chronic total occlusions in peripheral arteries.
- Facilitating guidewire passage through difficult peripheral arterial blockages.
- Supporting endovascular revascularization procedures for peripheral artery disease.
- Use in catheterization laboratories and vascular intervention settings when conventional crossing techniques are unsuccessful.
Practical Considerations
- The device is an over-the-wire catheter and should be used with compatible guidewire, sheath, and accessory systems according to the current manufacturer instructions for use.
- Operators should confirm that the catheter size and length are appropriate for the target vessel and access route.
- Use requires fluoroscopic imaging and experience with peripheral arterial chronic total occlusion interventions.
- The FDA record does not establish MRI safety; MRI conditions should be confirmed in the current labeling before scanning a patient with the device in place.
- Contraindications, warnings, and handling requirements should be reviewed in the current instructions for use. The device is not a substitute for appropriate patient selection or treatment of complications such as perforation, dissection, or embolization.
Frequently Asked Questions
What is the Crosser 14 OTW Catheter used for?
It is used for crossing chronic total occlusions in peripheral arteries, particularly when standard guidewire techniques are ineffective.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients with peripheral artery disease to assist in crossing chronic total occlusions.
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.