510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Temporary Carotid Catheter For Embolic Capture
Cardiovascular
The Temporary Carotid Catheter for Embolic Capture is a single-use percutaneous catheter system introduced into an artery via guidewire, featuring an embolic capture filter or occlusion balloon at the distal end to capture embolic material during angioplasty and stenting procedures. The device is intended to contain and remove thrombus and debris, protecting against stroke or other cerebrovascular events during carotid interventions. It is an FDA Class 2 device regulated under 21 CFR 870.1250 in the Cardiovascular specialty, with product code NTE, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
510(k) Clearances
36 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.