The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for Myopore(tm) Unipolar Sutureless Myocardial Leads.
| Device ID | K885175 |
| 510k Number | K885175 |
| Device Name: | MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS |
| Classification | Permanent Pacemaker Electrode |
| Applicant | POSSIS MEDICAL, INC. 8325 10TH AVENUE NORTH Minneapolis, MN 55427 |
| Contact | Robert J Scott |
| Correspondent | Robert J Scott POSSIS MEDICAL, INC. 8325 10TH AVENUE NORTH Minneapolis, MN 55427 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-14 |
| Decision Date | 1989-07-14 |