The following data is part of a premarket notification filed by Onset Medical Corporation with the FDA for Solopath Balloon Expandable Transfemoral Introducer.
| Device ID | K092014 |
| 510k Number | K092014 |
| Device Name: | SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | ONSET MEDICAL CORPORATION 13900 ALTON PARKWAY, SUITE 120 Irvine, CA 92618 |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2009-10-08 |