LUTONIX 035 Drug Coated Balloon PTA Catheter, Model 9010

No FDA recalls found in the data synced 6 Oct 2026.

Full name

LUTONIX® 035 Drug Coated Balloon PTA Catheter

Trade Name

LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010

Generic Name

Drug-coated peripheral transluminal angioplasty catheter

PMA Number

P170003 ↗

FDA Product Code

PRC

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

• Lutonix Drug Coated Balloon PTA Catheter

  Class III

  FDA PMA P130024 Active Approved 9 Oct 2014

• What specific types of blood vessels is the Lutonix 035 Drug Coated Balloon PTA Catheter designed to treat, and why is pre-dilatation required before use?

  The Lutonix 035 is designed to treat stenotic lesions in dysfunctional native arteriovenous dialysis fistulae with vessel diameters between 4 mm and 12 mm and lengths up to 80 mm. Pre-dilatation is required because the device is intended for use *after* initial vessel preparation to ensure safe and effective drug-coated balloon dilation, reducing the risk of complications during treatment.

• Is the Lutonix 035 Drug Coated Balloon PTA Catheter sterile, and how should it be handled before use?

  The Lutonix 035 is supplied as a **non-sterile** catheter, meaning it must be sterilized by the user prior to use in accordance with standard medical sterilization protocols (e.g., ethylene oxide or gamma irradiation) before clinical application. Always follow manufacturer guidelines for sterilization and handling to ensure safety.

• What are the key dimensions of the Lutonix 035 Drug Coated Balloon PTA Catheter, and how does this affect its clinical use?

  The catheter has a fixed shaft length of **75 cm** and is designed for vessels **4 mm to 12 mm in diameter** and up to **80 mm in lesion length**. These specifications ensure compatibility with common dialysis fistula geometries while allowing flexibility in treating varying stenosis lengths within the approved diameter range.

• Are there any special storage requirements for the Lutonix 035 Drug Coated Balloon PTA Catheter before use?

  Since the device is non-sterile, it should be stored in a **clean, dry environment** protected from moisture, dust, and extreme temperatures as per standard medical device storage guidelines. After sterilization, follow the manufacturer’s instructions for post-sterilization handling to maintain drug efficacy and device integrity.

• What regulatory pathway was followed for the Lutonix 035 Drug Coated Balloon PTA Catheter, and what does this mean for clinicians?

  The Lutonix 035 was approved via the **FDA’s PMA (Premarket Approval) process**, which requires rigorous clinical evidence demonstrating safety and effectiveness. This means clinicians can rely on established clinical data supporting its use for PTA in dialysis fistulae, though adherence to the approved indications (e.g., vessel size, pre-dilatation) remains critical for optimal outcomes.