WOLF Thrombectomy Device

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K182835 ↗

FDA Product Code

QEW

Device Class

Class II

Regulation

21 CFR Part 870.5150

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• What is the primary purpose of the Wolf Thrombectomy Device and how does it work?

  The Wolf Thrombectomy Device is designed for the mechanical removal of emboli and thrombi from peripheral arterial blood vessels. It combines aspiration and mechanical fragmentation to break down and clear blockages in vascular pathways, restoring blood flow without the need for surgical intervention. This approach helps maintain vascular integrity while addressing occlusions in catheterization labs or interventional radiology settings.

• Is the Wolf Thrombectomy Device intended for single-use or reusable applications, and what does that mean for clinical settings?

  The Wolf Thrombectomy Device is supplied as a single-use system, meaning each device is intended for one procedure only. This design ensures patient safety by eliminating cross-contamination risks and simplifies clinical workflows, as no reprocessing or sterilization is required between uses. Clinicians must adhere to manufacturer guidelines for proper storage and handling to maintain its integrity.

• How is the Wolf Thrombectomy Device packaged and stored, and does it require special handling?

  The device is supplied as a non-sterile system, intended for use in clinical settings like catheterization labs or interventional radiology. Since it is single-use, it must be stored according to the manufacturer’s guidelines to preserve its functionality. Proper storage ensures the device remains uncontaminated and ready for immediate use when needed, though clinicians should confirm specific storage conditions with 880 Medical, LLC.

• What regulatory pathway was followed for the Wolf Thrombectomy Device, and what does that mean for its use in clinical practice?

  The Wolf Thrombectomy Device received FDA 510(k) clearance (K182835) under the Traditional pathway, demonstrating it is substantially equivalent to a legally marketed predicate device. This clearance confirms it meets FDA safety and effectiveness standards for Peripheral Mechanical Thrombectomy With Aspiration, allowing its use in clinical practice as described in the approved labeling. The device is classified as Class II under regulation 870.5150.

• Are there different sizes or models of the Wolf Thrombectomy Device, and how might that affect its application?

  The device data includes multiple FEI numbers (e.g., 1000523114, 3002095335, etc.), which typically correspond to variations in catheter sizes, lengths, or other specifications. These differences allow clinicians to select the appropriate model based on the patient’s anatomy and the specific vascular occlusion being treated. For exact sizing details, refer to the manufacturer’s labeling or consult 880 Medical, LLC.