DESERET ARTERIAL CATHETER

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

PARKE-DAVIS CO.

The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Deseret Arterial Catheter.

Pre-market Notification Details

Device IDK851327
510k NumberK851327
Device Name:DESERET ARTERIAL CATHETER
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant PARKE-DAVIS CO. 870 PARKDALE RD. Rochester,  MI  48307
ContactEdward F Cleary
CorrespondentEdward F Cleary
PARKE-DAVIS CO. 870 PARKDALE RD. Rochester,  MI  48307
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-04
Decision Date1985-06-14

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