SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER - Dc-36 Series
by Horizon Medical Products, Inc.
510(k) K011916
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011916 | Date31 Oct 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MSD
- Models / Variants
- Dc-36 Series
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5540
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Super C Hemodialysis/Apheresis Chronic Catheter is a medical device designed for long-term vascular access in patients undergoing hemodialysis or apheresis therapy. It consists of a flexible tube inserted into a large vein, allowing for efficient blood flow during treatments. The device is available in multiple series (DC-36, DC-40, DC-45), offering different lengths and configurations to suit patient needs.
It is indicated for use in attaining short and long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein. The device received FDA 510(k) clearance under K011916 and is classified as a Class II catheter, hemodialysis, implanted. It is supplied non-sterile and intended for single use.
Other devices from Horizon Medical Products, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the Super C Hemodialysis/Apheresis Chronic Catheter used for?
It is indicated for attaining short and long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein, allowing efficient blood flow during treatments.
How is the Super C catheter supplied and is it reusable?
The device is supplied non-sterile and is intended for single use only, meaning it should not be reused after a procedure to ensure patient safety and device integrity.
What models or series are available for the Super C catheter?
The Super C Hemodialysis/Apheresis Chronic Catheter is available in multiple series: DC-36, DC-40, and DC-45, offering different lengths and configurations to suit varying patient anatomical needs and clinical requirements.