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U.S. Department of Health and Human Services

Product Classification

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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 CodeNTE
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Peripheral Interventional Devices Branch (PIDB)
Submission Type 510(k)
Regulation Number 870.1250
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff: Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions
Third Party Review Not Third Party Eligible
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