Aesculap Slim Clip Applier

Applier, Aneurysm Clip

Aesculap, Inc

The following data is part of a premarket notification filed by Aesculap, Inc with the FDA for Aesculap Slim Clip Applier.

Pre-market Notification Details

Device IDK211572
510k NumberK211572
Device Name:Aesculap Slim Clip Applier
ClassificationApplier, Aneurysm Clip
Applicant Aesculap, Inc 3773 Corporate Parkway Center Valley,  PA  18034
ContactPaul Amudala
CorrespondentPaul Amudala
Aesculap, Inc 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeHCI  
CFR Regulation Number882.4175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-21
Decision Date2021-12-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04046964726835 K211572 000
04046964725487 K211572 000
04046964725494 K211572 000
04046964725791 K211572 000
04046964725807 K211572 000
04046964725814 K211572 000
04046964725821 K211572 000
04046964725838 K211572 000
04046964725845 K211572 000
04046964725852 K211572 000
04046964725869 K211572 000
04046964725876 K211572 000
04046964725883 K211572 000
04046964725890 K211572 000
04046964726804 K211572 000
04046964726811 K211572 000
04046964726828 K211572 000
04046964725470 K211572 000

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