Medical Device Manufacturer · US , West Valley City , UT

Scientia Vascular, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2023
7
Total
7
Cleared
0
Denied

Scientia Vascular, Inc. is a neurovascular medical device company focused on advanced access and therapy systems. The company operates with a manufacturing facility in West Valley City, US, and specializes in innovative guidewires, catheters, and microcatheters for minimally invasive neurological procedures.

Scientia Vascular has received 7 FDA 510(k) clearances from 7 total submissions, with all submissions focused on Neurology devices. The company's regulatory activity spans from 2023 to 2026, with its most recent clearance in 2026, demonstrating continued innovation and active market presence.

The company's product portfolio centers on patented microfabrication technology for neurovascular access systems. Key product lines include guidewires designed for enhanced torque transmission and navigation through complex brain vasculature, as well as catheters engineered for predictable movement and precise therapy delivery. Leadership includes experienced professionals from leading endovascular companies, bringing extensive expertise in product development and regulatory strategy.

Explore the complete list of cleared device names, product codes, and clearance dates in the 510(k) database.

FDA 510(k) Regulatory Record - Scientia Vascular, Inc.
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