5F GUIDING CATHETER

Catheter, Percutaneous

GUIDANT CORP.

The following data is part of a premarket notification filed by Guidant Corp. with the FDA for 5f Guiding Catheter.

Pre-market Notification Details

Device IDK000598
510k NumberK000598
Device Name:5F GUIDING CATHETER
ClassificationCatheter, Percutaneous
Applicant GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara,  CA  95054 -2807
ContactMargaret Anderson
CorrespondentMargaret Anderson
GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara,  CA  95054 -2807
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-23
Decision Date2000-03-24

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