FDA.reportPublic FDA data

SCIENTIA VASCULAR

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30095464663009546466SCIENTIA VASCULAR1N2026-01-012460 South 3270 West West Valley City UT US 84119
30095464663009546466SCIENTIA VASCULAR1N2026-01-012460 South 3270 West West Valley City UT US 84119

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3520461602506671K260223Aristotle Mini GuidewireMOF2026-08-06
3520462071374236K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireMOF2026-04-29
3520461190049506K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus GuidewireMOF2025-04-01
1405711373561260K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus GuidewireMOF2025-04-01
1405711037324232K242301Socrates 38 CatheterQJP2024-12-04
3520461566662815K242301Socrates 38 CatheterQJP2024-12-04
1405711473014559K231954Aristotle 18 Guidewire; Aristotle 24 GuidewireMOF2023-08-01
3520461838440831K231954Aristotle 18 Guidewire; Aristotle 24 GuidewireMOF2023-08-01
3520461141267055K223913Socrates Aspiration SystemNRY2023-09-20
1405711160698692K223913Socrates Aspiration SystemNRY2023-09-20
1405711543396260K223560Plato 17 MicrocatheterQJP2023-08-21
3520461683850141K223560Plato 17 MicrocatheterQJP2023-08-21
1405711310334830K222437Aristotle Colossus GuidewireMOF2023-01-26
3520462011960557K222437Aristotle Colossus GuidewireMOF2023-01-26
1405711124258069K210601Plato 17 MicrocatheterDQY2021-04-28
3520461377455924K210601Plato 17 MicrocatheterDQY2021-04-28
3520461388642305K201760Zoom 14 GuidewireDQX2020-07-29
1405711871920072K201760Zoom 14 GuidewireDQX2020-07-29
1405711440903910K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support ProfileDQX2019-10-30
3520461569067725K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support ProfileDQX2019-10-30
3520461767237528K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support ProfileMOF2019-03-22
1405711828334183K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support ProfileMOF2019-03-22
1405711468406917K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard ProfileMOF2018-08-07
3520461656232890K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support ProfileDQX2018-01-22
1405712006929028K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support ProfileDQX2018-01-22
1405711132315203K170406Plato MICROCATH 27B MicrocatheterDQO2017-04-18
1405711603308962K143398Plato MICROCATH 27B MicrocatheterDQO2015-06-26
1405712067635283K121734PLATO MICROCATH 27 MICROCATHETERDQO2012-07-30
1405711756941968

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MOF132026-08-06
DQX82020-07-29
QJP42024-12-04
DQO42017-04-18
NRY22023-09-20
DQY22021-04-28