The following data is part of a premarket notification filed by Scientia Vascular Llc with the FDA for Plato 17 Microcatheter.
| Device ID | K210601 |
| 510k Number | K210601 |
| Device Name: | Plato 17 Microcatheter |
| Classification | Catheter, Percutaneous |
| Applicant | Scientia Vascular LLC 3487 West 2100 South Suite 100 West Valley City, UT 84119 |
| Contact | Amy Mcmanus |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-03-01 |
| Decision Date | 2021-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818075010479 | K210601 | 000 |
| 00818075010462 | K210601 | 000 |
| 00818075010455 | K210601 | 000 |