The following data is part of a premarket notification filed by Reverse Medical Corporation with the FDA for Reverse Medical Report Guide Catheter System.
| Device ID | K102418 |
| 510k Number | K102418 |
| Device Name: | REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM |
| Classification | Catheter, Percutaneous |
| Applicant | REVERSE MEDICAL CORPORATION 13700 ALTON PARKWAY SUITE 167 Irvine, CA 92618 |
| Contact | Amy Eskina |
| Correspondent | Mark Job 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 | 2010-08-25 |
| Decision Date | 2011-04-15 |
| Summary: | summary |