The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Directional Boot.
| Device ID | K813150 |
| 510k Number | K813150 |
| Device Name: | DIRECTIONAL BOOT |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | PACESETTER SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-06 |
| Decision Date | 1981-12-02 |