← Back to catalogue
Aristotle 14 Guidewire - Aristotle Colossus Guidewire
FDA 510(k)Class II (US FDA 510(k))
510(k) K243938
Identifiers
- 510(k) Number
- K243938 FDA 510(k)
- FDA Product Code
- MOF FDA 510(k)
- Models / Variants
- Aristotle 14 Guidewire FDA 510(k)Aristotle 18 Guidewire FDA 510(k)Aristotle 24 Guidewire FDA 510(k)Zoom Wire 14 Guidewire FDA 510(k)Aristotle Colossus Guidewire FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1330 FDA 510(k)
- Regulation Number
- 870.1330 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Aristotle 14 Guidewire - Aristotle Colossus Guidewire by Scientia Vascular, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 5 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243938 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scientia Vascular, Inc.
Sources (1)
- FDA 510(k) K243938 24 fields · synced Jun 18, 2026