510(k) K192783
Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile by
Scientia Vascular, LLC
— Product Code DQX
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2019
- Date Received
- September 30, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type