Product Classification

• Device: device, vascular, for promoting embolization
• Regulation Description: Vascular embolization device.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: KRD
• Premarket Review: Office of Cardiovascular Devices (OHT2); Coronary and Peripheral Interventional Devices (DHT2C)
• Submission Type: 510(k)
• Regulation Number: 870.3300
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Guidance Document

• Vascular and Neurovascular Embolization Devices - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible