đź“‹ FDA Reference
Cardima Inc Forerunner
Cardima
Summary: The Cardima Inc Forerunner is a venous stent used to support veins and improve blood flow. It is typically used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K951603 ↗
Decision Date ?
October 5, 1995
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Cardima Inc Forerunner received FDA clearance through the 510(k) pathway on October 5, 1995. It is manufactured by Cardima and classified as a Class 2 medical device.
What It Is
The Cardima Inc Forerunner is a venous stent designed to be implanted in veins to maintain patency and improve blood flow. It is typically made of a biocompatible metal mesh that expands once deployed in the vessel. This device is used to treat venous obstructions and is critical in procedures where maintaining vein openness is necessary.
FDA-Cleared Indications
- The FDA record classifies the device under product code DQY: Catheter, Percutaneous, 21 CFR 870.1250.
- The available record lists the FDA indications as “Summary” and does not provide a specific clinical indication.
Clinical Applications
- Use as a percutaneous catheter in procedures consistent with the device's FDA-cleared labeling.
- Use in catheter-based procedures when the device's current labeling and instructions for use identify the relevant indication.
Practical Considerations
- Do not rely on the available record to identify the Forerunner as a venous stent; confirm the device name, model, current labeling, and instructions for use before clinical use.
- The available FDA entry does not specify device dimensions, delivery-system compatibility, materials, or deployment characteristics.
- MRI safety or conditional status is not established by the information provided; review the current labeling and official MRI conditions.
- Contraindications, warnings, and handling requirements should be taken from the device-specific instructions for use.
- A 510(k) clearance indicates substantial equivalence to a legally marketed predicate device; it does not by itself establish a broad indication for venous stenting.
Frequently Asked Questions
What is Cardima Inc Forerunner used for?
The Cardima Inc Forerunner is used to treat venous obstructions by maintaining vein patency and improving blood flow.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients with venous obstructions needing stenting to restore or maintain blood flow.
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.