MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

Catheter, Percutaneous

INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.

The following data is part of a premarket notification filed by Invatec Innovative Technologies, S.r.l. with the FDA for Modification To Amphirion Deep 0.014 Otw Pta Balloon Catheter.

Pre-market Notification Details

Device IDK050073
510k NumberK050073
Device Name:MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
ClassificationCatheter, Percutaneous
Applicant INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. 4600 Nathan Lane North Plymouth,  MN  55442
ContactMike Winegar
CorrespondentMike Winegar
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. 4600 Nathan Lane North Plymouth,  MN  55442
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-12
Decision Date2005-02-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08033477050652 K050073 000
08033477045870 K050073 000
08033477045894 K050073 000
08033477045931 K050073 000
08033477045955 K050073 000
08033477045979 K050073 000
08033477046013 K050073 000
08033477046037 K050073 000
08033477046051 K050073 000
08033477046099 K050073 000
08033477046112 K050073 000
08033477046136 K050073 000
08033477050416 K050073 000
08033477050454 K050073 000
08033477050478 K050073 000
08033477050638 K050073 000
08033477045856 K050073 000

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