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

Clearance record K113163

PENUMBRA SYSTEM MAX · Penumbra, Inc. · decided 2011-11-23 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
JET5MAXJETD-APENUMBRA, INC.NRY00814548019734
Penumbra System3MAXC-APENUMBRA, INC.NRY00814548019932
Penumbra System3MAXCPENUMBRA, INC.NRY00814548012490
Penumbra System4MAXCKITPENUMBRA, INC.NRY00814548016740
Penumbra System3MAXCKITPENUMBRA, INC.NRY00814548016757
JET5MAXJETDKITPENUMBRA, INC.NRY00814548019802
JET5MAXJETDPENUMBRA, INC.NRY00814548019796
Penumbra SystemACE643D3MXSYS-APENUMBRA, INC.DQY NRY00815948020108
Penumbra System4MAXCPENUMBRA, INC.NRY00814548012414
Penumbra System3MAXC-BPENUMBRA, INC.NRY00814548019956
JET5MAXJETDKIT-APENUMBRA, INC.NRY00814548019741
Penumbra SystemACE683DVELSYS-APENUMBRA, INC.DQY NRY00815948020085
Penumbra SystemPST2PENUMBRA, INC.NRY00814548012025
Penumbra SystemACE603D3MXSYS-APENUMBRA, INC.DQY NRY00815948020092
Penumbra System3MAXCKIT-BPENUMBRA, INC.NRY00814548019963
Systems ConfigurationACE603DVELSYS-APENUMBRA, INC.DQY NRY00815948020061
Penumbra SystemACE683D3MXSYS-APENUMBRA, INC.DQY NRY00815948020115
Penumbra System4MAXCMPPENUMBRA, INC.NRY00814548012391
Penumbra System3MAXCKIT-APENUMBRA, INC.NRY00814548019949
Penumbra System3MAXSPENUMBRA, INC.NRY00814548012483
Penumbra System4MAXC130PENUMBRA, INC.NRY00814548012407
Penumbra SystemACE643DVELSYS-APENUMBRA, INC.DQY NRY00815948020078