The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Lead Adapters #'s 6016,6022,6017 Etc.
| Device ID | K831160 |
| 510k Number | K831160 |
| Device Name: | LEAD ADAPTERS #'S 6016,6022,6017 ETC |
| Classification | Pacemaker Lead Adaptor |
| Applicant | CARDIAC PACEMAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-11 |
| Decision Date | 1983-05-09 |