The following data is part of a premarket notification filed by Reverse Medical Corporation with the FDA for Reverse Medical Reflex Guide Catheter.
| Device ID | K110055 |
| 510k Number | K110055 |
| Device Name: | REVERSE MEDICAL REFLEX GUIDE CATHETER |
| 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 | 2011-01-10 |
| Decision Date | 2011-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536018044 | K110055 | 000 |
| 00847536003286 | K110055 | 000 |
| 00847536003262 | K110055 | 000 |
| 00847536003248 | K110055 | 000 |
| 00847536003033 | K110055 | 000 |
| 00847536003019 | K110055 | 000 |
| 00847536002999 | K110055 | 000 |
| 00847536002975 | K110055 | 000 |
| 00847536002951 | K110055 | 000 |
| 00847536000094 | K110055 | 000 |
| 00847536000070 | K110055 | 000 |
| 00847536000056 | K110055 | 000 |
| 00847536000032 | K110055 | 000 |
| 00847536003309 | K110055 | 000 |
| 00847536017740 | K110055 | 000 |
| 00847536018020 | K110055 | 000 |
| 00847536018006 | K110055 | 000 |
| 00847536017986 | K110055 | 000 |
| 00847536017962 | K110055 | 000 |
| 00847536017948 | K110055 | 000 |
| 00847536017924 | K110055 | 000 |
| 00847536017900 | K110055 | 000 |
| 00847536017894 | K110055 | 000 |
| 00847536017887 | K110055 | 000 |
| 00847536017863 | K110055 | 000 |
| 00847536017849 | K110055 | 000 |
| 00847536017795 | K110055 | 000 |
| 00847536000018 | K110055 | 000 |