The following data is part of a premarket notification filed by Scientia Vascular , Llc with the FDA for Plato Microcath 27b Microcatheter.
| Device ID | K143398 |
| 510k Number | K143398 |
| Device Name: | Plato MICROCATH 27B Microcatheter |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | SCIENTIA VASCULAR , LLC 2700 SOUTH 900 WEST SUITE D Salt Lake City, UT 84119 |
| Contact | Sharon Rockwell |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-11-26 |
| Decision Date | 2015-06-26 |
| Summary: | summary |