The following data is part of a premarket notification filed by Nano4imaging Gmbh with the FDA for Mr Wire Guide Wire Straight, Mr Wire Guide Wire Angled.
| Device ID | K173423 |
| 510k Number | K173423 |
| Device Name: | MR Wire Guide Wire Straight, MR Wire Guide Wire Angled |
| Classification | Wire, Guide, Catheter |
| Applicant | Nano4Imaging GmbH Pauwelsstrasse 17 Aachen, DE 52074 |
| Contact | Christoph R. Manegold |
| Correspondent | Judith Harrington G&L Scientific 9 Highland Ave Derry, NH 03038 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-01 |
| Decision Date | 2017-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251244500436 | K173423 | 000 |
| 04251244500429 | K173423 | 000 |