R350 guidewire— 510(k) K151234
Substantially EquivalentVascular Solutions, Inc.
FDA 510(k) clearance K151234 for R350 guidewire, Substantially Equivalent on 2015-11-18. Applicant: Vascular Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Vascular Solutions, Inc.
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code DQX
view allMore clearances from Vascular Solutions, Inc.
view allAdverse 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.