NovaCross Microcatheter

Catheter, Percutaneous

Nitiloop Ltd.

The following data is part of a premarket notification filed by Nitiloop Ltd. with the FDA for Novacross Microcatheter.

Pre-market Notification Details

Device IDK172297
510k NumberK172297
Device Name:NovaCross Microcatheter
ClassificationCatheter, Percutaneous
Applicant Nitiloop Ltd. 4 Ha'Omanut Street Netanya,  IL 4250438
ContactChanan Schneider
CorrespondentMichael Daniel
Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville,  NV  89460
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-31
Decision Date2017-10-18
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.