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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 - Standard FDA UDI
Model / Reference
ACL-200-002 FDA UDI
Description
Guidewire - Standard FDA UDI

Identifiers

Catalog Number
ACL-200-002 FDA UDI
Primary DI / UDI-DI
00818075010691 FDA UDI
510(k) Number
K222437 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

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

K222437 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scientia Vascular, Inc.

Sources (1)

  • FDA UDI e7a298d6-7687-4919-8d5b-3680ddc8d294 36 fields · synced Jun 6, 2026