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

Clearance record K162901

Penumbra 3D Revascularization Device · Penumbra, Inc. · decided 2017-04-20 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Penumbra SystemJET73DVELSYS-APENUMBRA, INC.DQY NRY00815948020146
Penumbra SystemACE643D3MXSYS-APENUMBRA, INC.DQY NRY00815948020108
Penumbra SystemACE683DVELSYS-APENUMBRA, INC.DQY NRY00815948020085
Penumbra SystemACE603D3MXSYS-APENUMBRA, INC.DQY NRY00815948020092
Penumbra SystemPSR3D-APENUMBRA, INC.NRY00814548017853
Penumbra SystemPSR3DPENUMBRA, INC.NRY00814548017839
Systems ConfigurationACE603DVELSYS-APENUMBRA, INC.DQY NRY00815948020061
Penumbra SystemACE683D3MXSYS-APENUMBRA, INC.DQY NRY00815948020115
Penumbra SystemACE643DVELSYS-APENUMBRA, INC.DQY NRY00815948020078