FDA.reportPublic FDA data

Plato

Primary DI
00818075010479
Brand
Plato
Company
SCIENTIA VASCULAR LLC
Model
17-160-090
Catalog number
PL17-160-090
Device description
Microcatheter 90degree tip
Published
2023-01-26
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
DQYCatheter, Percutaneous
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210601000
K223560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210601000Plato 17 MicrocatheterScientia Vascular, LLC2021-04-28DQY
K223560000Plato 17 MicrocatheterScientia Vascular, Inc.2023-08-21QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818075010479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818075010479008180750104798180750104790818075010479

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Inner Diameter0.017Inch
Catheter Working Length160Centimeter
Outer Diameter0.57Millimeter
Pressure300Pound per Square Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888.385.9016regulatory@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
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
00818075010004Aristotle14-200-001A14-200-0012020-02-24
00818075010011Aristotle14-200-002A14-200-0022020-02-24
00818075010028Aristotle14-300-001A14-300-0012020-02-24
00818075010035Aristotle14-300-002A14-300-0022020-02-24
00818075011261Aristotle01672AMN-225-0022026-09-21
00818075011209SocratesSC038-156-0012025-05-27
00818075011216SocratesSC038-127-0012025-05-27
00818075010080Plato27BPL273-150-0012016-08-24
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850085183026FreeClimb 46 Catheter x125cm with Tenzing 4ROUTE 92 MEDICALQJP2026-10-12
00850085183033FreeClimb 46 Catheter x143 cm with Tenzing 4ROUTE 92 MEDICALQJP2026-10-12
00850085183040Tenzing 4 Delivery CatheterROUTE 92 MEDICALQJP2026-10-12
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0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.QJP2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.QJP2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00810068568998Next Generation 088 CatheterBALT USA LLCQJP2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCQJP2026-10-01
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00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
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
00884450838167Ventrax™Merit Medical Systems, Inc.DQY2026-01-13
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