Penumbra System Reperfusion Catheter JET 7

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 Jet 7.

Pre-market Notification Details

Device IDK173761
510k NumberK173761
Device Name:Penumbra System Reperfusion Catheter JET 7
ClassificationCatheter, Thrombus Retriever
Applicant Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
ContactMichaela Mahl
CorrespondentMichaela Mahl
Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-11
Decision Date2018-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814548019918 K173761 000
00815948023208 K173761 000
00815948023215 K173761 000
00815948023222 K173761 000
00815948023239 K173761 000
00815948023246 K173761 000
00814548019819 K173761 000
00814548019826 K173761 000
00814548019833 K173761 000
00814548019840 K173761 000
00814548019857 K173761 000
00814548019925 K173761 000
00814548019864 K173761 000
00814548019871 K173761 000
00814548019888 K173761 000
00814548019895 K173761 000
00814548019901 K173761 000
00815948023192 K173761 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.