The following data is part of a premarket notification filed by Vital 5 with the FDA for Vital 5 Releaf Catheter.
| Device ID | K122661 |
| 510k Number | K122661 |
| Device Name: | VITAL 5 RELEAF CATHETER |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | VITAL 5 570 RESEARCH PARK WAY SUITE 102 North Logan, UT 84341 |
| Contact | T. Wade Fallin |
| Correspondent | T. Wade Fallin VITAL 5 570 RESEARCH PARK WAY SUITE 102 North Logan, UT 84341 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-31 |
| Decision Date | 2013-02-27 |
| Summary: | summary |