The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Bio-medicus Percutaneous Cannula & Introducer Set.
| Device ID | K884129 |
| 510k Number | K884129 |
| Device Name: | BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET |
| Classification | Catheter, Percutaneous |
| Applicant | BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Contact | John R Dalpee |
| Correspondent | John R Dalpee BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-30 |
| Decision Date | 1988-12-21 |