Penumbra System ACE

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.

Pre-market Notification Details

Device IDK142458
510k NumberK142458
Device Name:Penumbra System ACE
ClassificationCatheter, Thrombus Retriever
Applicant PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda,  CA  94502
ContactMichaela Mahl
CorrespondentMichaela Mahl
PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda,  CA  94502
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-02
Decision Date2015-05-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814548017532 K142458 000
00814548016498 K142458 000
00814548016481 K142458 000
00814548016467 K142458 000
00814548016207 K142458 000
00814548016191 K142458 000
00814548016184 K142458 000
00814548016177 K142458 000
00814548016160 K142458 000
00814548014005 K142458 000
00814548013992 K142458 000
00814548013985 K142458 000
00814548013978 K142458 000
00814548013961 K142458 000
00815948022850 K142458 000
00814548016504 K142458 000
00814548016511 K142458 000
00814548017525 K142458 000
00814548017518 K142458 000
00814548017501 K142458 000
00814548017495 K142458 000
00814548017488 K142458 000
00814548016603 K142458 000
00814548016597 K142458 000
00814548016580 K142458 000
00814548016573 K142458 000
00814548016566 K142458 000
00814548016559 K142458 000
00814548016542 K142458 000
00814548016535 K142458 000
00814548016528 K142458 000
00815948022843 K142458 000

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