DeviceClearance

Product code NTE— Cardiovascular

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Classification name
Temporary Carotid Catheter For Embolic Capture
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Total cleared
36
First cleared
Most recent

FDA classification 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”

— U.S. Food and Drug Administration, device classification record for product code NTE under 21 CFR 870.1250, via openFDA

Market context for product code NTE

FDA has cleared 36 devices under product code NTE between 2004 and 2023, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code NTE

Adverse events under product code NTE

product code NTE
Death
28
Injury
1,348
Malfunction
771
Total
2,147

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code NTE

Data sourced from openFDA. This site is unofficial and independent of the FDA.