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 |