The following data is part of a premarket notification filed by Nitiloop Ltd. with the FDA for Novacross Microcatheter.
Device ID | K172297 |
510k Number | K172297 |
Device Name: | NovaCross Microcatheter |
Classification | Catheter, Percutaneous |
Applicant | Nitiloop Ltd. 4 Ha'Omanut Street Netanya, IL 4250438 |
Contact | Chanan Schneider |
Correspondent | Michael Daniel Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, NV 89460 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-31 |
Decision Date | 2017-10-18 |
Summary: | summary |