The following data is part of a premarket notification filed by Scientia Vascular Llc with the FDA for Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile.
| Device ID | K173235 |
| 510k Number | K173235 |
| Device Name: | Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile |
| Classification | Wire, Guide, Catheter |
| Applicant | Scientia Vascular LLC 3487 West 2100 South Suite 100 West Valley City, UT 84119 |
| Contact | David Sabodski |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-10-05 |
| Decision Date | 2018-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818075010035 | K173235 | 000 |
| 00818075010028 | K173235 | 000 |
| 00818075010011 | K173235 | 000 |
| 00818075010004 | K173235 | 000 |