Extended Life Capd Solution Transfer Set 5C4153
by Travenol Laboratories, S.A.
510(k) K851207
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK851207 | Date8 Apr 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KDJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5630
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Extended Life Capd Solution Transfer Set 5C4153 is a disposable administration set designed for peritoneal dialysis. It facilitates the transfer of dialysis solution during the peritoneal dialysis process.
This device is supplied as a single-use, disposable administration set. It is regulated under FDA 510(k) clearance K851207 and falls under the classification for peritoneal dialysis administration sets.
Other devices from Travenol Laboratories, S.A.
Questions
AI-generated answers, 25 Sep 2026
What is the primary purpose of the 5C4153 transfer set?
This device is designed to facilitate the transfer of dialysis solution during the peritoneal dialysis process, acting as an administration set for the procedure.
Is this transfer set intended for multiple uses?
No, the Extended Life CAPD Solution Transfer Set 5C4153 is supplied as a single-use, disposable administration set and should not be reused.
What is the regulatory status of this device?
This device is regulated under FDA 510(k) clearance K851207, which indicates it has been found substantially equivalent to legally marketed predicate devices for use in peritoneal dialysis.