The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Cardiopulmonary Cannula Tubing.
| Device ID | K861096 |
| 510k Number | K861096 |
| Device Name: | CARDIOPULMONARY CANNULA TUBING |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Contact | Debra P See |
| Correspondent | Debra P See BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-24 |
| Decision Date | 1986-05-21 |