The following data is part of a premarket notification filed by Scientia Vascular Llc with the FDA for Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile.
| Device ID | K181828 |
| 510k Number | K181828 |
| Device Name: | Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-09 |
| Decision Date | 2018-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818075010073 | K181828 | 000 |
| 00818075010066 | K181828 | 000 |
| 00818075010042 | K181828 | 000 |
| 00818075010059 | K181828 | 000 |