Penumbra, Inc. - FDA 510(k) Cleared Devices

Penumbra, Inc. is a global healthcare company headquartered in Alameda, California. The company focuses on innovative medical devices for neurology and cardiovascular interventions.

Penumbra has maintained a strong FDA 510(k) regulatory record since its first clearance in 2005. The company has received 84 FDA 510(k) clearances from 86 total submissions. Recent clearances span neurology devices including thrombectomy and access catheters, as well as cardiovascular aspiration systems and delivery catheters. The company remains actively cleared, with the latest FDA 510(k) clearance in 2026.

Penumbra's product portfolio emphasizes aspiration and thrombectomy technologies across both neuro and vascular specialties. Notable product lines include the INDIGO® Aspiration System, Penumbra System reperfusion catheters, and delivery microcatheters designed for minimally invasive interventions.

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

4 devices have linked clinical trials registered on ClinicalTrials.gov.