Product Classification

• Device: temporary carotid catheter for embolic capture
• Regulation Description: Percutaneous catheter.
• Definition: This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: NTE
• Premarket Review: Office of Cardiovascular Devices (OHT2); Coronary and Peripheral Interventional Devices (DHT2C)
• Submission Type: 510(k)
• Regulation Number: 870.1250
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Guidance Documents

• Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff

• Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations: Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible