Product Classification

• Device: sensor, pressure, aneurysm, implantable
• Regulation Description: Implantable Intra-aneurysm Pressure Measurement System.
• Definition: This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: NQH
• Premarket Review: Circulatory Support, Structural and Vascular Devices (DHT2B); Circulatory Support, Structural and Vascular Devices (DHT2B)
• Submission Type: 510(k)
• Regulation Number: 870.2855
• 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 Documents

• Federal Register: Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System; Availability

• Implantable Intra-Aneurysm Pressure Measurement System - Class II Special Controls Guidance Document

Third Party Review

Not Third Party Eligible