Penumbra System (Reperfusion Catheter RED 62)

Catheter, Thrombus Retriever

Penumbra, Inc.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System (reperfusion Catheter Red 62).

Pre-market Notification Details

Device IDK203440
510k NumberK203440
Device Name:Penumbra System (Reperfusion Catheter RED 62)
ClassificationCatheter, Thrombus Retriever
Applicant Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
ContactAditi Kolla
CorrespondentAditi Kolla
Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-23
Decision Date2021-05-20


Device IdentifiersubmissionNumberSupplement
00815948023536 K203440 000
00815948023475 K203440 000

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