HORIZON XVU (FFR)

Wire, Guide, Catheter

MENNEN MEDICAL LTD.

The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Horizon Xvu (ffr).

Pre-market Notification Details

Device IDK123792
510k NumberK123792
Device Name:HORIZON XVU (FFR)
ClassificationWire, Guide, Catheter
Applicant MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 Rehovot,  IL 76100
ContactIfat Shwarts
CorrespondentIfat Shwarts
MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 Rehovot,  IL 76100
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-10
Decision Date2013-08-30
Summary:summary

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