RAPIDO CUT-AWAY GUIDING CATHETER

Catheter, Percutaneous

GUIDANT CORPORATION

The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Rapido Cut-away Guiding Catheter.

Pre-market Notification Details

Device IDK031505
510k NumberK031505
Device Name:RAPIDO CUT-AWAY GUIDING CATHETER
ClassificationCatheter, Percutaneous
Applicant GUIDANT CORPORATION 4100 HAMLINE AVE NORTH St Paul,  MN  55112 -5798
ContactShah M Hilali
CorrespondentShah M Hilali
GUIDANT CORPORATION 4100 HAMLINE AVE NORTH St Paul,  MN  55112 -5798
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-14
Decision Date2003-06-25
Summary:summary

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