PALMAZ BILIARY STENT

Catheter, Percutaneous

JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS

The following data is part of a premarket notification filed by Johnson & Johnson Interventional Systems with the FDA for Palmaz Biliary Stent.

Pre-market Notification Details

Device IDK905720
510k NumberK905720
Device Name:PALMAZ BILIARY STENT
ClassificationCatheter, Percutaneous
Applicant JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS 35 TECHNOLOGY DR. P.O. BOX 4917 Warren,  NJ  07060
ContactRaymond E Ursick
CorrespondentRaymond E Ursick
JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS 35 TECHNOLOGY DR. P.O. BOX 4917 Warren,  NJ  07060
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-21
Decision Date1991-02-05

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