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 |