← Back to catalogue

Aristotle

FDA UDI

Class II (US FDA UDI)

by Scientia Vascular, Inc.

Identity

Trade Name
Aristotle FDA UDI
Generic Name
Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name
Guidewire 200cm Support FDA UDI
Model / Reference
14-200-003 FDA UDI
Description
Guidewire 200cm Support FDA UDI

Identifiers

Catalog Number
Z14-200-003 FDA UDI
Primary DI / UDI-DI
00818075010233 FDA UDI
510(k) Number
K201760 FDA UDI
FDA Product Code
DQX FDA UDI
MOF FDA UDI
GMDN Term
Cardiac/peripheral vascular guidewire, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1330 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Guidewire Length — 200 Centimeter FDA UDI
Guidewire Diameter — 0.014 Inch FDA UDI

Category: Cardiac/peripheral vascular guidewire, single-use

Aristotle by Scientia Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac/peripheral vascular guidewire, single-use.

Cleared under the same submission

K201760 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Scientia Vascular, Inc.

Sources (1)

  • FDA UDI fb7b37f8-5e71-4ff6-810e-42c2a0254e7d 38 fields · synced Jun 8, 2026