Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009546466

FEI Number

3009546466

Entity Name

SCIENTIA VASCULAR

City/State/Country

West Valley City, UT, US

Establishment Address

2460 South 3270 West, West Valley City, UT 84119, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Scientia Vascular (Owner Number: 10040465)

Owner / Operator Contact Address

2460 South 3270 West, West Valley City, UT 84119, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222437

PMA Number

N/A

All Registered Proprietary Names

Plato MICROCATH 27B Microcatheter Aristotle 18 Guidewire Plato 17 Microcatheter Aristotle 14 Guidewire Aristotle 18 Guidewire Zoom Wire 14 Guidewire Aristotle Colossus Guidewire Aristotle 24 Guidewire Plato MICROCATH 27B Microcatheter Aristotle 24 Guidewire Plato MICROCATH 27 Microcatheter Aristotle Colossus Guidewire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2016-08-18
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2019-12-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-12-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-09-24
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2021-09-24
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-04-17
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-09-15
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2025-09-15
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-04-19
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2017-04-19
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2017-04-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-12-05
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2019-12-05
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2013-01-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-01-31
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2023-01-31

Official Correspondent

Amy McManus

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Scientia Vascular

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009546466. Last updated year: 2026. Please use registration number 3009546466 when referencing this establishment in official correspondence.