The following data is part of a premarket notification filed by Scientia Vascular Llc with the FDA for Zoom 14 Guidewire.
| Device ID | K201760 |
| 510k Number | K201760 |
| Device Name: | Zoom 14 Guidewire |
| 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 | 2020-06-29 |
| Decision Date | 2020-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818075010264 | K201760 | 000 |
| 00818075010257 | K201760 | 000 |
| 00818075010240 | K201760 | 000 |
| 00818075010233 | K201760 | 000 |