The following data is part of a premarket notification filed by Cardiomed Supplies, Inc. with the FDA for 14f Dual Floating Dialysis Catheter/tray.
| Device ID | K042672 |
| 510k Number | K042672 |
| Device Name: | 14F DUAL FLOATING DIALYSIS CATHETER/TRAY |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | CARDIOMED SUPPLIES, INC. 5 GORMLEY INDUSTRIAL AVENUE Gormley, Ontario, CA L0h 1g0 |
| Contact | Christian G Dube |
| Correspondent | Christian G Dube CARDIOMED SUPPLIES, INC. 5 GORMLEY INDUSTRIAL AVENUE Gormley, Ontario, CA L0h 1g0 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-29 |
| Decision Date | 2005-03-23 |