The following data is part of a premarket notification filed by Pace Medical with the FDA for Temporary Pacemaker Extension Cable, Models 5235, 5235a, 5235v, Temporary Pacemaker Surgical Extension Cable, Models 528.
| Device ID | K001180 |
| 510k Number | K001180 |
| Device Name: | TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Contact | Robert C Mace |
| Correspondent | Robert C Mace PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-11 |
| Decision Date | 2000-06-27 |