510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220398Substantially Equivalent

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire

Scientia Vascular, West Valley City UT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220398 is the FDA 510(k) clearance record for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire, a class II device, cleared for Scientia Vascular, LLC on under FDA product code MOF (Guide, Wire, Catheter, Neurovasculature). FDA records list 19 510(k) clearances for Scientia Vascular, LLC, from to . As of , FDA records show no recalls naming K220398.

Clearance record

Decision date
Received
(392 days to decision)
Product code
MOF Guide, Wire, Catheter, Neurovasculature
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Scientia Vascular, LLC 3487 W. 2100 S., Suite 100, West Valley City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MOF

Trailing 12 months
12 clearances under product code MOF in the twelve months to October 2026, August 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MOF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20262
March 20262
April 20262
May 20260
June 20260
July 20261
August 20263
September 20261
October 20260