The following data is part of a premarket notification filed by Arrow International, Inc. with the FDA for Step-tip Chronic Hemodialysis Catheter.
| Device ID | K040666 |
| 510k Number | K040666 |
| Device Name: | STEP-TIP CHRONIC HEMODIALYSIS CATHETER |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Brandon Epting |
| Correspondent | Brandon Epting ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-15 |
| Decision Date | 2004-05-14 |
| Summary: | summary |