DEVICE: Plato (00818075010479)

Device Identifier (DI) Information

Plato
17-160-090
In Commercial Distribution
PL17-160-090
SCIENTIA VASCULAR LLC
00818075010479
GS1

1
011234178 *Terms of Use
Microcatheter 90degree tip
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Device Characteristics

MR Unsafe
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
10691 Vascular microcatheter
A 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DQY Catheter, Percutaneous
QJP Catheter, Percutaneous, Neurovasculature
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K210601 000
K223560 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 35 Degrees Celsius
Special Storage Condition, Specify: Keep dry
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Clinically Relevant Size

[?]
Size Type Text
Catheter Inner Diameter: 0.017 Inch
Catheter Working Length: 160 Centimeter
Outer Diameter: 0.57 Millimeter
Pressure: 300 Pound per Square Inch
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Device Record Status

7a54d459-044e-470a-bdc9-94a4c7d2485a
September 18, 2023
2
January 26, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
888.385.9016
regulatory@scientiavascular.com
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