The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Ela Medical Pacing Leads Pmc 860 Pmcf 860 Pbcf860.
| Device ID | K851731 |
| 510k Number | K851731 |
| Device Name: | ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Contact | Tom S Anderson |
| Correspondent | Tom S Anderson ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-25 |
| Decision Date | 1985-08-29 |