The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Diatek Cannon-catheter, Model Cc5500.
| Device ID | K022662 |
| 510k Number | K022662 |
| Device Name: | DIATEK CANNON-CATHETER, MODEL CC5500 |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Thomas Nickel |
| Correspondent | Thomas Nickel ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-09 |
| Decision Date | 2003-05-09 |
| Summary: | summary |