Plato 17 Microcatheter— 510(k) K210601
Substantially EquivalentScientia Vascular, LLC
FDA 510(k) clearance K210601 for Plato 17 Microcatheter, Substantially Equivalent on 2021-04-28. Applicant: Scientia Vascular, LLC. Device class: 2.
Clearance details
- Applicant
- Scientia Vascular, LLC
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Valley City, UT, US
Recent devices under product code DQY
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
- K201760 — Zoom 14 Guidewire
- K192783 — Aristotle 24 Guidewire, 200cm, Soft Profile +2 more
- K183608 — Aristotle 18 Guidewire, 200cm, Soft Profile +2 more
- K181828 — Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile
Adverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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 →
Recalls naming K210601
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K210601.
Data sourced from openFDA. This site is unofficial and independent of the FDA.