Penumbra System (RED 68 Reperfusion Catheter)

Catheter, Thrombus Retriever

Penumbra, Inc.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System (red 68 Reperfusion Catheter).

Pre-market Notification Details

Device IDK211411
510k NumberK211411
Device Name:Penumbra System (RED 68 Reperfusion Catheter)
ClassificationCatheter, Thrombus Retriever
Applicant Penumbra, Inc. One Penumbra Place Alameda,  CA  95132
ContactMicaela Victoria
CorrespondentMicaela Victoria
Penumbra, Inc. One Penumbra Place Alameda,  CA  95132
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-06
Decision Date2021-07-01


Device IdentifiersubmissionNumberSupplement
00815948024120 K211411 000
00815948024113 K211411 000
00815948024106 K211411 000
00815948024090 K211411 000
00815948023901 K211411 000
00815948023895 K211411 000
00815948023888 K211411 000
00815948023871 K211411 000
00815948024137 K211411 000

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