CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT

Stents, Drains And Dilators For The Biliary Ducts

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Palmaz Genesis Transhepatic Biliary Stent.

Pre-market Notification Details

Device IDK012087
510k NumberK012087
Device Name:CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
ContactChuck Ryan
CorrespondentChuck Ryan
CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-03
Decision Date2001-08-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20705032057629 K012087 000
20705032057445 K012087 000
20705032057537 K012087 000
20705032057575 K012087 000
20705032057612 K012087 000
20705032057391 K012087 000
20705032057414 K012087 000
20705032057438 K012087 000
20705032057452 K012087 000
20705032057476 K012087 000
20705032057490 K012087 000
20705032057506 K012087 000
20705032057520 K012087 000
20705032057544 K012087 000
20705032057568 K012087 000
20705032057582 K012087 000
20705032057605 K012087 000
20705032057407 K012087 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.