Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile— 510(k) K173235

Name: FDA 510(k) clearance K173235
Creator: U.S. Food and Drug Administration
Published: 2018-01-22

Substantially Equivalent

Scientia Vascular, LLC

FDA 510(k) clearance K173235 for Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile, Substantially Equivalent on 2018-01-22. Applicant: Scientia Vascular, LLC. Device class: 2.

Clearance details

Applicant: Scientia Vascular, LLC
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2017-10-05
Decision date: 2018-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Valley City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQX

view all

K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 0352026-09-03
K253667 — Accoat Guide Wire2026-07-14
K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire2026-07-13
K254137 — InQwire Amplatz Guide Wire2026-05-22
K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

More clearances from Scientia Vascular, LLC

view all

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, 2020-01-01 through 2026-04-23. 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.