Submission Details
| 510(k) Number | K160594 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 01, 2016 |
| Decision Date | November 22, 2016 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
MRWire Guide Wire
Nov 2016
Decision
266d
Days
Class 2
Risk
About This 510(k) Submission
K160594 is an FDA 510(k) clearance for the MRWire Guide Wire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Nano4imaging GmbH (Aachen, DE). The FDA issued a Cleared decision on November 22, 2016, 266 days after receiving the submission on March 1, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.
Device Classification
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1330 |
Manufacturer
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