The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Pacemaker Lead Adapter.
| Device ID | K810551 |
| 510k Number | K810551 |
| Device Name: | PACEMAKER LEAD ADAPTER |
| Classification | Pacemaker Lead Adaptor |
| Applicant | PACESETTER SYSTEMS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-02 |
| Decision Date | 1981-04-23 |