The following data is part of a premarket notification filed by Medtronic Blood Systems, Inc. with the FDA for Unipolar Atrial Temporary Pacing Lead,model 6492.
| Device ID | K944966 |
| 510k Number | K944966 |
| Device Name: | UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | MEDTRONIC BLOOD SYSTEMS, INC. 7000 CENTRAL AVENUE NE P.O. BOX 1350 Minneapolis, MN 55440 |
| Contact | Susan Tesmer |
| Correspondent | Susan Tesmer MEDTRONIC BLOOD SYSTEMS, INC. 7000 CENTRAL AVENUE NE P.O. BOX 1350 Minneapolis, MN 55440 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-11 |
| Decision Date | 1995-07-14 |