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 | K121404 |
| 510k Number | K121404 |
| Device Name: | SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM |
| Classification | Introducer, Catheter |
| Applicant | ONSET MEDICAL CORPORATION 13900 ALTON PARKWAY, SUITE 120 Irvine, CA 92618 |
| Contact | Joseph Bishop |
| Correspondent | Joseph Bishop ONSET MEDICAL CORPORATION 13900 ALTON PARKWAY, SUITE 120 Irvine, CA 92618 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-10 |
| Decision Date | 2013-05-03 |
| Summary: | summary |