POD Packing Coil

Device, Neurovascular Embolization

Penumbra, Inc.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Pod Packing Coil.

Pre-market Notification Details

Device IDK170852
510k NumberK170852
Device Name:POD Packing Coil
ClassificationDevice, Neurovascular Embolization
Applicant Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
ContactAditi Kolla
CorrespondentAditi Kolla
Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-22
Decision Date2017-07-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00814548017693 K170852 000
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00814548017822 K170852 000
00814548017815 K170852 000
00814548017808 K170852 000
00814548017792 K170852 000
00814548017686 K170852 000

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