The following data is part of a premarket notification filed by Nano4imaging Gmbh with the FDA for Mrwire Guide Wire.
Device ID | K160594 |
510k Number | K160594 |
Device Name: | MRWire Guide Wire |
Classification | Wire, Guide, Catheter |
Applicant | NANO4IMAGING GMBH PAUWELSSTR. 17 Aachen, DE 52074 |
Contact | Christoph R. Manegold |
Correspondent | Judith Harrington TURNSTONE ALLIANCE GROUP, LLC 45 ROCKEFELLER PLAZA, SUITE 2000 New York, NY 10111 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-01 |
Decision Date | 2016-11-22 |
Summary: | summary |