The following data is part of a premarket notification filed by Daig Corp. with the FDA for Endocard. Pacing Lead Std. Length Pl202.
| Device ID | K800350 |
| 510k Number | K800350 |
| Device Name: | ENDOCARD. PACING LEAD STD. LENGTH PL202 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | DAIG CORP. 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 | 1980-02-15 |
| Decision Date | 1980-05-28 |