The following data is part of a premarket notification filed by Diatek, Inc. with the FDA for Diatek Cannon-cath #cc2400, Cc2800, Cc3200, Cc3600,cc5500. Cc2400pc, Cc2800pc, Cc3200pc(32 Cm), Cc3200pc(36 Cm).
| Device ID | K010399 |
| 510k Number | K010399 |
| Device Name: | DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | DIATEK, INC. 101 N. CHESTNUT ST. #300 Winston-salem, NC 27101 |
| Contact | Todd Cassidy |
| Correspondent | Todd Cassidy DIATEK, INC. 101 N. CHESTNUT ST. #300 Winston-salem, NC 27101 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-09 |
| Decision Date | 2001-08-14 |