6F ENVOY GUIDING CATHETER

Catheter, Percutaneous

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for 6f Envoy Guiding Catheter.

Pre-market Notification Details

Device IDK982770
510k NumberK982770
Device Name:6F ENVOY GUIDING CATHETER
ClassificationCatheter, Percutaneous
Applicant CORDIS CORP. 14000 N.W. 57TH COURT Miami Lakes,  FL  33014
ContactMartine D Schneider
CorrespondentMartine D Schneider
CORDIS CORP. 14000 N.W. 57TH COURT Miami Lakes,  FL  33014
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-23
Decision Date1998-08-18
Summary:summary

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