Identity
- Trade Name
- Aristotle FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- Guidewire 300cm Extra Support FDA UDI
- Model / Reference
- 14-300-004 FDA UDI
- Description
- Guidewire 300cm Extra Support FDA UDI
Identifiers
- Catalog Number
- Z14-300-004 FDA UDI
- Primary DI / UDI-DI
- 00818075010264 FDA UDI
- 510(k) Number
- K201760 FDA UDI
- FDA Product Code
- MOF FDA UDIDQX 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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Guidewire Diameter — 0.014 Inch FDA UDIGuidewire Length — 300 Centimeter 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
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Cleared under the same submission
K201760 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Scientia Vascular, Inc.
Sources (1)
- FDA UDI f8438e73-7a89-4824-a5cf-ee0d05bcbd83 38 fields · synced May 30, 2026