The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Model 492-03 Polyflex Implantable Pacing Lead.
| Device ID | K853410 |
| 510k Number | K853410 |
| Device Name: | MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
| Contact | Lisa S Jones |
| Correspondent | Lisa S Jones INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-13 |
| Decision Date | 1985-10-11 |