MR Wire Guide Wire Straight, MR Wire Guide Wire Angled— 510(k) K173423
Substantially EquivalentNano4imaging GmbH
FDA 510(k) clearance K173423 for MR Wire Guide Wire Straight, MR Wire Guide Wire Angled, Substantially Equivalent on 2017-11-17. Applicant: Nano4imaging GmbH.
Clearance details
- Applicant
- Nano4imaging GmbH
- Product code
- Code DQX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Aachen, DE
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.