Impella CP Introducer

Introducer, Catheter

Abiomed, Inc.

The following data is part of a premarket notification filed by Abiomed, Inc. with the FDA for Impella Cp Introducer.

Pre-market Notification Details

Device IDK192769
510k NumberK192769
Device Name:Impella CP Introducer
ClassificationIntroducer, Catheter
Applicant Abiomed, Inc. 22 Cherry Hill Drive Danvers,  MA  01923
ContactRobert Stewart
CorrespondentRobert Stewart
Abiomed, Inc. 22 Cherry Hill Drive Danvers,  MA  01923
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2019-11-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813502011715 K192769 000
00813502011708 K192769 000
00813502011661 K192769 000
00813502011654 K192769 000
00813502011500 K192769 000
00813502011302 K192769 000
00813502010015 K192769 000
00813502013474 K192769 000

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