NTEClass II

Temporary Carotid Catheter For Embolic Capture

21 CFR 870.1250 / Cardiovascular

NTE is the FDA product code for Temporary Carotid Catheter For Embolic Capture, a class II device type, regulated under 21 CFR 870.1250. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 36 510(k) clearances under this code, the most recent dated 2023-04-27, and 30 recalls.

Classification record

Product code: NTE
Device name: Temporary Carotid Catheter For Embolic Capture
FDA 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: 21 CFR 870.1250
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 36
Ingested recalls: 30

Clearances, product code NTE

By decision year

36 clearances under product code NTE with a decision year between 2004 and 2023, 2006 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code NTE by decision year
Year	Clearances
2004	2
2005	3
2006	4
2007	1
2008	3
2009	3
2010	1
2011	4
2012	3
2014	1
2015	3
2016	1
2018	1
2019	1
2020	1
2021	1
2022	1
2023	2

Applicants with the most clearances

Product code NTE

Applicants holding the most 510(k) clearances under product code NTE
Applicant	Clearances
Abbott Vascular	5
Boston Scientific Corporation	5
Medtronic, Inc.	4
W. L. Gore & Associates, Inc.	4
Silk Road Medical	3
Abbott Medical	2
Abbott Vascular-Vascular Solutions	2
Cardiovascular Systems Incorporated	2
Cordis US Corp.	2
Gardia Medical	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order