PERIFUSE CATHETER

Anesthesia Conduction Kit

SMITHS MEDICAL ASD, INC.

The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Perifuse Catheter.

Pre-market Notification Details

Device IDK121525
510k NumberK121525
Device Name:PERIFUSE CATHETER
ClassificationAnesthesia Conduction Kit
Applicant SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene,  NH  03431
ContactChristine Lloyd
CorrespondentChristine Lloyd
SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene,  NH  03431
Product CodeCAZ  
CFR Regulation Number868.5140 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-23
Decision Date2012-08-02
Summary:summary

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