OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB

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 Opta5 Pta Balloon Catheter, Powerflex Pta Balloon Catheter, Ultra-thin Diamond Balloon Catheter, Palmaz Balloon Expandab.

Pre-market Notification Details

Device IDK972825
510k NumberK972825
Device Name:OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
ContactMirjam Barboza
CorrespondentMirjam Barboza
CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-09
Decision Date1997-10-07
Summary:summary

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