The following data is part of a premarket notification filed by Onset Medical Corporation with the FDA for Solopath Re-collapsible Access System.
| Device ID | K152498 |
| 510k Number | K152498 |
| Device Name: | SoloPath Re-Collapsible Access System |
| Classification | Introducer, Catheter |
| Applicant | ONSET MEDICAL CORPORATION 13900 ALTON PARKWAY, SUITE 120 Irvine, CA 92618 |
| Contact | Monika Mcdole-russell |
| Correspondent | Monika Mcdole-russell TERUMO Corporation 265 Davidson Ave, Suite 320 Somerset, NJ 08873 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-01 |
| Decision Date | 2016-01-05 |
| Summary: | summary |