FDA Product Code NTE: Temporary Carotid Catheter For Embolic Capture
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
Leading manufacturers include Cardiovascular Systems, Inc. and MicroVention, Inc..
FDA 510(k) Cleared Temporary Carotid Catheter For Embolic Capture Devices (Product Code NTE)
About Product Code NTE - Regulatory Context
510(k) Submission Activity
36 total 510(k) submissions under product code NTE since 2004, with 36 receiving FDA clearance (average review time: 66 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
NTE devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →