📋 FDA Reference
Scoutpro Acs
Summary: The scoutpro acs is a venous stent used primarily in vascular procedures to support veins. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K101776 ↗
Decision Date ?
July 23, 2010
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The scoutpro acs was cleared through the FDA 510(k) pathway on July 23, 2010. It is manufactured by Biotronik and classified as a Class 2 medical device.
What It Is
The scoutpro acs is a venous stent designed to provide structural support to veins, particularly in cases where venous flow is compromised. It is a self-expanding stent made from a biocompatible material, ensuring it integrates well with the body's tissues. The device is delivered via a catheter and expands upon deployment to maintain patency in the treated vein.
FDA-Cleared Indications
- The FDA record identifies the device under product code DQY: percutaneous catheter, regulated under 21 CFR 870.1250.
- The supplied FDA indications field contains only “Statement” and does not specify a clinical indication.
Clinical Applications
- Use in a percutaneous catheter-based vascular procedure consistent with the device’s FDA-cleared labeling.
- Use by trained clinicians when the device’s official instructions for use identify the applicable anatomy, access route, and procedure.
Practical Considerations
- Confirm the current FDA clearance summary and manufacturer’s instructions for use before documenting the device as a venous stent.
- Do not assume that the device is indicated for deep vein thrombosis, chronic venous insufficiency, iliac-vein obstruction, or central-vein obstruction without verified labeling.
- Verify catheter dimensions, working length, compatibility with guidewires and accessory devices, and any vessel-size requirements in the instructions for use.
- MRI safety, including MR Safe, MR Conditional, or MR Unsafe status, cannot be determined from the supplied FDA record and should be confirmed in the manufacturer’s labeling.
- Review contraindications, warnings, deployment instructions, and storage requirements in the current manufacturer documentation.
Frequently Asked Questions
What is scoutpro acs used for?
The scoutpro acs is used to support veins in patients with venous obstructions, improving blood flow and reducing symptoms associated with conditions like deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in both hospital and outpatient settings.
What are the FDA-cleared indications?
The scoutpro acs is indicated for use in patients with narrowed or blocked veins, such as those with deep vein thrombosis or chronic venous insufficiency.
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.