The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Endocardial Leads 414s & 515s.
| Device ID | K802816 |
| 510k Number | K802816 |
| Device Name: | ENDOCARDIAL LEADS 414S & 515S |
| Classification | Permanent Pacemaker Electrode |
| Applicant | SIEMENS ELEMA AB 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-07 |
| Decision Date | 1981-01-16 |