510(k) K173423

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

K173423 is an FDA 510(k) premarket notification submitted by Nano4imaging GmbH for the device "MR Wire Guide Wire Straight, MR Wire Guide Wire Angled". The FDA issued a decision of Substantially Equivalent on November 17, 2017. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Nano4imaging GmbH has at least 2 other 510(k) clearances on record.

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