The following data is part of a premarket notification filed by Scientia Vascular Llc with the FDA for Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile.
| Device ID | K192783 |
| 510k Number | K192783 |
| Device Name: | Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile |
| Classification | Wire, Guide, Catheter |
| Applicant | Scientia Vascular LLC 3487 West 2100 South Suite 100 West Valley City, UT 84119 |
| Contact | Amy Mcmanus |
| Correspondent | Amy Mcmanus Scientia Vascular LLC 3487 West 2100 South Suite 100 West Valley City, UT 84119 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818075010141 | K192783 | 000 |
| 00818075010134 | K192783 | 000 |
| 00818075010127 | K192783 | 000 |