510(k) clearances

Aristotle 65 Macrowire

Scientia Vascular · Cardiovascular

K254181Substantially EquivalentTraditionalMOF
Open FDA's page for this record
Third party flag
N
City
West Valley City
Advisory committee description
Cardiovascular
Address 1
2460 S. 3270 W.
Statement or summary
Summary
Product code
MOF
Zip code
84119
Applicant
Scientia Vascular
Decision date
2026-09-16
Decision code
SESE
Country code
US
Device name
Aristotle 65 Macrowire
Advisory committee
CV
Contact
Bailey Johannsen
K number
K254181
State
UT
Date received
2025-12-23
Review advisory committee
NE
Postal code
84119
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Guide, Wire, Catheter, Neurovasculature
Medical specialty description
Cardiovascular
Regulation number
870.1330
Device class
2
Registration number
3017210488, 3006283319, 3007628272, 3039020025, 3018070217, 3009092139, 3015531723, 3003780911, 3015550451, 3009957947, 1220477, 3026317086, 3014162263, 3008853977, 3008114965, 1721676, 3012931345, 3008837339, 3039642752, 3010163695, 3014590708, 2011171, 3030452144, 3003775027, 8023054, 3009546466, 3034543750, 3013556777, 3009121749, 2029214, 1226348, 3004102031, 3013656790, 3016119728
FEI number
3017210488, 3006283319, 3007628272, 3039020025, 3018070217, 3009092139, 3015531723, 3003780911, 3015550451, 3009957947, 1220477, 3026317086, 3014162263, 3004216185, 3008853977, 3008114965, 1721676, 3012931345, 3008837339, 3039642752, 3010163695, 3014590708, 2011171, 3030452144, 3003775027, 3009546466, 3034543750, 3013556777, 3009121749, 1000220862, 3004102031, 3002947440, 3013656790, 3016119728
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.