Penumbra System ACE 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 Ace 68 Reperfusion Catheter.

Pre-market Notification Details

Device IDK161064
510k NumberK161064
Device Name:Penumbra System ACE 68 Reperfusion Catheter
ClassificationCatheter, Thrombus Retriever
Applicant Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
ContactCharles Denault
CorrespondentCharles Denault
Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-15
Decision Date2016-06-12
Summary:summary

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