Product Classification

• Device: catheter, thrombus retriever
• Regulation Description: Percutaneous catheter.
• Definition: The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Neurology
• Product Code: NRY
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
• 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: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Guidance Documents

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

• Pre-Clinical and Clinical Studies for Neurothrombectomy Devices - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible