The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Cardifix Ez Bipolar/unipolar Endocardial Pacing Lead.
| Device ID | K955550 |
| 510k Number | K955550 |
| Device Name: | CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD |
| Classification | Permanent Pacemaker Electrode |
| Applicant | INTERMEDICS, INC. 4000 TECHNOLOGY DR. Angleton, TX 77515 |
| Contact | Lori Kleinschrodt Holder |
| Correspondent | Lori Kleinschrodt Holder INTERMEDICS, INC. 4000 TECHNOLOGY DR. Angleton, TX 77515 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-05 |
| Decision Date | 1996-06-19 |
| Summary: | summary |