PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054

Catheter, Thrombus Retriever

PENUMBRA, INC.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System Separator Flex (026,032,041,054), Models Psf026, Psf032, Psf041, Psf054.

Pre-market Notification Details

Device IDK100769
510k NumberK100769
Device Name:PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054
ClassificationCatheter, Thrombus Retriever
Applicant PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda,  CA  94502
ContactMichaela Mahl
CorrespondentMichaela Mahl
PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda,  CA  94502
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-18
Decision Date2010-05-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814548010434 K100769 000
00814548010427 K100769 000
00814548010410 K100769 000
00814548010403 K100769 000
00814548010328 K100769 000

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