The following data is part of a premarket notification filed by Tpl-cordis, Inc. with the FDA for Modified Ancor & Hi-flex Unipolar Active Fix. Lead.
| Device ID | K885240 |
| 510k Number | K885240 |
| Device Name: | MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD |
| Classification | Permanent Pacemaker Electrode |
| Applicant | TPL-CORDIS, INC. 7400 SO. TUCSON WAY Englewood, CO 80112 |
| Contact | Duane A Schultz |
| Correspondent | Duane A Schultz TPL-CORDIS, INC. 7400 SO. TUCSON WAY Englewood, CO 80112 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-21 |
| Decision Date | 1989-02-10 |