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 IDK052791
510k NumberK052791
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
ContactStephanie Robinson
CorrespondentStephanie Robinson
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 Received2005-10-03
Decision Date2005-11-04
Summary:summary

NIH GUDID Devices

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