510(k) K173423

MR Wire Guide Wire Straight, MR Wire Guide Wire Angled by Nano4imaging GmbH — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2017
Date Received
November 1, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type