The following data is part of a premarket notification filed by Daig Corp. with the FDA for Actifix (r) Bipolar Endocardial Screw-in Lead.
| Device ID | K874183 |
| 510k Number | K874183 |
| Device Name: | ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD |
| Classification | Permanent Pacemaker Electrode |
| Applicant | DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Contact | J Fleischhacker |
| Correspondent | J Fleischhacker DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-13 |
| Decision Date | 1988-01-29 |