Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile

Guide, Wire, Catheter, Neurovasculature

Scientia Vascular LLC

The following data is part of a premarket notification filed by Scientia Vascular Llc with the FDA for Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile.

Pre-market Notification Details

Device IDK183608
510k NumberK183608
Device Name:Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile
ClassificationGuide, Wire, Catheter, Neurovasculature
Applicant Scientia Vascular LLC 3487 West 2100 South Suite 100 West Valley City,  UT  84119
ContactDavid Sabodski
CorrespondentDavid Sabodski
Scientia Vascular LLC 3487 West 2100 South Suite 100 West Valley City,  UT  84119
Product CodeMOF  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-26
Decision Date2019-03-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00818075010110 K183608 000
00818075010103 K183608 000
00818075010097 K183608 000

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