PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054

Catheter, Thrombus Retriever

PENUMBRA, INC.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System (pennumbra Reperfusion Catheter 054), Model Psc054; (penumbra Separator 054), Model Pss054.

Pre-market Notification Details

Device IDK090752
510k NumberK090752
Device Name:PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054
ClassificationCatheter, Thrombus Retriever
Applicant PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda,  CA  94502
ContactLouise Musante
CorrespondentLouise Musante
PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda,  CA  94502
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-20
Decision Date2009-09-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814548017433 K090752 000
00814548012742 K090752 000
00814548012759 K090752 000
00814548012766 K090752 000
00814548012780 K090752 000
00814548012797 K090752 000
00814548012803 K090752 000
00814548013626 K090752 000
00814548016771 K090752 000
00814548017402 K090752 000
00814548017419 K090752 000
00814548017426 K090752 000
00814548010380 K090752 000

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