PENUMBRA DDC CATHETERS

Catheter, Percutaneous

PENUMBRA, INC.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra Ddc Catheters.

Pre-market Notification Details

Device IDK122772
510k NumberK122772
Device Name:PENUMBRA DDC CATHETERS
ClassificationCatheter, Percutaneous
Applicant PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda,  CA  94502
ContactSeth Schulman
CorrespondentSeth Schulman
PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda,  CA  94502
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-10
Decision Date2012-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814548013275 K122772 000
00814548012674 K122772 000
00814548012667 K122772 000

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