6F HYDROLYSER THROMBECTOMY CATHETER

Catheter, Embolectomy

CORDIS CORP.

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

Pre-market Notification Details

Device IDK990771
510k NumberK990771
Device Name:6F HYDROLYSER THROMBECTOMY CATHETER
ClassificationCatheter, Embolectomy
Applicant CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
ContactAriel Mactavish
CorrespondentAriel Mactavish
CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-09
Decision Date1999-06-25
Summary:summary

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