The following data is part of a premarket notification filed by Horizon Medical Products, Inc. with the FDA for Super C Hemodialysis/apheresis Chronic Catheter, Model Dc-36 Series, Dc-40 Series, Dc-45 Series.
| Device ID | K011916 |
| 510k Number | K011916 |
| Device Name: | SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | HORIZON MEDICAL PRODUCTS, INC. 1 HORIZON WAY Manchester, GA 31816 |
| Contact | Penny M Northcutt |
| Correspondent | Penny M Northcutt HORIZON MEDICAL PRODUCTS, INC. 1 HORIZON WAY Manchester, GA 31816 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-20 |
| Decision Date | 2001-10-31 |
| Summary: | summary |