Rx Accunet Embolic Protection System

No FDA recalls on record, checked 5 Oct 2026.

Full name

Modification to: Rx Accunet Embolic Protection System

510(k) Number

K052166 ↗

FDA Product Code

NTE

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Steerable Stylet Accessory

  Class II

  FDA 510(k) K053019 Active Cleared 3 Mar 2006

• Rapido Cut-Away Bleedback Control Valve (Bbcv), Model 7568

  Class II

  FDA 510(k) K031903 Active Cleared 3 Mar 2004

• Modification to Rx Herculink 14 Biliary Stent System, Models 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,

  Class II

  FDA 510(k) K993588 Active Cleared 17 Nov 1999

• Hi-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic Coating

  Class II

  FDA 510(k) K031678 Active Cleared 26 Aug 2003

• ACS Hi-Torque Cross IT 100XT, 200XT, and 300XT Guide Wires with Hydrocoat Hydrophilic Coating

  Class II

  FDA 510(k) K990639 Active Cleared 25 Mar 1999

• Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model Vh-3000 Open recall

  Class II

  FDA 510(k) K052274 Active Cleared 21 Sep 2005

See all devices from Guidant Corp. →

• What is the Rx Accunet Embolic Protection System used for?

  The Rx Accunet Embolic Protection System is a Temporary Carotid Catheter designed to prevent embolic material—such as thrombus or debris—from dislodging during carotid artery angioplasty and stenting. It deploys a filter basket within the artery to trap particulate matter while maintaining uninterrupted blood flow, reducing the risk of stroke or other complications.

• How is the Rx Accunet Embolic Protection System supplied and prepared for use?

  The system is supplied as a sterile, single-use device, ensuring it is ready for immediate clinical use in catheterization labs without additional sterilization. This design minimizes contamination risks and aligns with best practices for procedural safety.

• What carotid artery diameters is the Rx Accunet Embolic Protection System compatible with?

  The device is compatible with carotid arteries ranging from 3.25 mm to 7.0 mm in diameter, allowing flexibility for standard interventional techniques while ensuring proper fit and function during procedures.

• Is the Rx Accunet Embolic Protection System reusable, or is it intended for single-use?

  The Rx Accunet Embolic Protection System is explicitly designed for single-use only. This prevents cross-contamination between patients and ensures optimal performance, as reuse could compromise sterility and structural integrity.

• What regulatory pathway does the Rx Accunet Embolic Protection System follow?

  The system holds FDA 510(k) clearance for modifications, including refinements to the filter basket strut and enhanced manufacturing testing. It is classified under FDA regulation 870.1250 and falls under the National Embolic Protection Technology (NTE) product code, adhering to Class II medical device standards.