Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile— 510(k) K181828
Substantially EquivalentScientia Vascular, LLC
FDA 510(k) clearance K181828 for Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile, Substantially Equivalent on 2018-08-07. Applicant: Scientia Vascular, LLC. Device class: 2.
Clearance details
- Applicant
- Scientia Vascular, LLC
- Product code
- Code MOF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- West Valley City, UT, US
Recent devices under product code MOF
view allMore clearances from Scientia Vascular, LLC
view all- K220398 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire
- K210601 — Plato 17 Microcatheter
- K201760 — Zoom 14 Guidewire
- K192783 — Aristotle 24 Guidewire, 200cm, Soft Profile +2 more
- K183608 — Aristotle 18 Guidewire, 200cm, Soft Profile +2 more
Adverse events under product code MOF
product code MOF- Death
- 6
- Injury
- 137
- Total
- 143
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.