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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K203440

Penumbra System (Reperfusion Catheter RED 62) · Penumbra, Inc. · decided 2021-05-20 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
REDRED62S-BPENUMBRA, INC.NRY00815948023475
REDRED62SKIT-BPENUMBRA, INC.NRY00815948023536