The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Model 431-06 Polyflex Implantable Pacing Lead.
| Device ID | K864002 |
| 510k Number | K864002 |
| Device Name: | MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD |
| Classification | Permanent Pacemaker Electrode |
| Applicant | INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
| Contact | Ken Bishop |
| Correspondent | Ken Bishop INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-14 |
| Decision Date | 1986-11-20 |