FDA.reportPublic FDA data

Plato

Primary DI
00818075010080
Brand
Plato
Company
SCIENTIA VASCULAR LLC
Model
27B
Catalog number
PL273-150-001
Device description
Catheter
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic
DQYCatheter, Percutaneous
KRACatheter, Continuous Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
DQYCatheter, PercutaneousCardiovascular2
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143398000
K170406000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143398000Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC2015-06-26DQO
K170406000Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC2017-04-18DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818075010080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818075010080008180750100808180750100800818075010080

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry, Keep away from heat

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-385-9016ap@scientiavascular.com

Regulatory Flags#

DUNS number
011234178
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818075011261Aristotle01672AMN-225-0022026-09-21
00818075011209SocratesSC038-156-0012025-05-27
00818075011216SocratesSC038-127-0012025-05-27
00818075011179Aristotle01862A18-200-0012025-08-01
00818075011186Aristotle01863A18-200-0022025-08-01
00818075011193Aristotle01864A18-200-0032025-08-01
00818075010059Volo14-200-002V14-200-0022020-03-03
00818075010042Volo14-200-001V14-200-0012020-02-24
00818075010066Volo14-300-001V14-300-0012020-02-24
00818075010073Volo14-300-002V14-300-0022020-02-24
00818075010776SocratesSC038-156-0012023-11-14
00818075010790SocratesTS-254-1102023-11-14
00818075011025SocratesSC038-127-0012023-11-14
00818075010233Aristotle14-200-003Z14-200-0032023-09-25
00818075010240Aristotle14-200-004Z14-200-0042023-09-25
00818075010257Aristotle14-300-003Z14-300-0032023-09-25
00818075010264Aristotle14-300-004Z14-300-0042023-09-25
00818075010455Plato17-160-000PL17-160-0002023-01-26
00818075010462Plato17-160-045PL17-160-0452023-01-26
00818075010479Plato17-160-090PL17-160-0902023-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.KRA2026-09-29
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
00884450787793Impress®Merit Medical Systems, Inc.DQO2026-09-18
00884450788868Impress®Merit Medical Systems, Inc.DQO2026-09-18
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00810123710393ClotTriever BOLD CatheterInari Medical, Inc.KRA2025-04-09
00810123710577Artix Thin-Walled SheathInari Medical, Inc.DQY2024-11-11
00810123710577Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-11
00810123710560Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-07