The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for Bipolar Sutureless Myocardial Pacing Leads.
| Device ID | K910528 |
| 510k Number | K910528 |
| Device Name: | BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS |
| Classification | Permanent Pacemaker Electrode |
| Applicant | POSSIS MEDICAL, INC. 2905 NORTHWEST BLVD. Minneapolis, MN 55441 -2644 |
| Contact | Michael G Schultz |
| Correspondent | Michael G Schultz POSSIS MEDICAL, INC. 2905 NORTHWEST BLVD. Minneapolis, MN 55441 -2644 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-08 |
| Decision Date | 1991-08-09 |