Abiomed 14Fr Low Profile Introducer Set

Introducer, Catheter

Abiomed Inc.

The following data is part of a premarket notification filed by Abiomed Inc. with the FDA for Abiomed 14fr Low Profile Introducer Set.

Pre-market Notification Details

Device IDK222113
510k NumberK222113
Device Name:Abiomed 14Fr Low Profile Introducer Set
ClassificationIntroducer, Catheter
Applicant Abiomed Inc. 22 Cherry Hill Drive Danvers,  MA  01923
ContactKen Ryder
CorrespondentKen Ryder
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 Received2022-07-18
Decision Date2022-10-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813502013252 K222113 000
00813502012996 K222113 000
00813502013474 K222113 000
00813502012736 K222113 000
00813502012729 K222113 000
00813502013269 K222113 000

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