Lutonix Drug Coated Balloon PTA Catheter

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

Full name

Lutonix Drug Coated Balloon (Dcb)

Trade Name

Lutonix Drug Coated Balloon PTA Cateter

Generic Name

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

PMA Number

P130024 ↗

FDA Product Code

ONU

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

• Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9010

  Class III

  FDA PMA P170003 Active Approved 25 Aug 2017

• What types of arteries is the Lutonix Drug Coated Balloon designed to treat, and what are the key size limitations for use?

  The Lutonix Drug Coated Balloon is specifically designed for treating de novo (new) or restenotic (recurrent) lesions in **native superficial femoral or popliteal arteries**. It is intended for vessels with reference diameters between **4–6 mm** and lesion lengths up to **150 mm**. The device requires pre-dilation before use, meaning it should only be deployed after an initial balloon angioplasty has prepared the artery.

• Is the Lutonix Drug Coated Balloon intended for reuse, or is it a single-use device? How is it supplied?

  The Lutonix Drug Coated Balloon is a **single-use, sterile catheter**. It is not designed for reuse, and each catheter is intended for one procedure only. The device is supplied pre-sterilized, ready for immediate use in controlled clinical settings like catheterization labs.

• What is the regulatory pathway for this device, and how was its approval determined?

  The Lutonix Drug Coated Balloon follows the **FDA Pre-Market Approval (PMA)** pathway, which is required for Class III medical devices. It received **FDA_PMA approval (P130024)** after undergoing a rigorous review process, including an **expedited review** (flagged as expedited). The approval was based on clinical data demonstrating its safety and effectiveness for the specified indications, as outlined in the **advisory committee description (Cardiovascular, CV)**.

• Are there specific size variations available for the Lutonix Drug Coated Balloon, and how would a clinician determine the correct size for a patient?

  The Lutonix Drug Coated Balloon is available in various sizes, with the **035 reference diameter** being a key model. The correct size is determined by the **reference vessel diameter (4–6 mm)** and lesion length (up to 150 mm). Clinicians should measure the patient’s artery using imaging techniques (e.g., angiography) before selecting the appropriate catheter size to ensure compatibility with the target lesion.

• What storage requirements or handling instructions should be followed for the Lutonix Drug Coated Balloon?

  While specific storage instructions are not detailed in the provided data, the Lutonix Drug Coated Balloon is supplied as a **sterile, single-use device**. It should be stored in a clean, dry environment, protected from physical damage, and used within its expiration date. Proper handling includes avoiding contamination and ensuring the catheter remains intact until immediate pre-procedure use.