The following data is part of a premarket notification filed by Scientia Vascular Llc with the FDA for Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile.
| Device ID | K183608 |
| 510k Number | K183608 |
| Device Name: | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | Scientia Vascular LLC 3487 West 2100 South Suite 100 West Valley City, UT 84119 |
| Contact | David Sabodski |
| Correspondent | David Sabodski Scientia Vascular LLC 3487 West 2100 South Suite 100 West Valley City, UT 84119 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818075010110 | K183608 | 000 |
| 00818075010103 | K183608 | 000 |
| 00818075010097 | K183608 | 000 |