FKO — Catheter, Peritoneal Dialysis, Single Use Class II
FDA product code FKO covers "Catheter, Peritoneal Dialysis, Single Use", a Class II medical device regulated under 21 CFR 876.5630. Submissions are reviewed by the Gastroenterology, Urology panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FKO
- Device Class
- Class II
- Regulation Number
- 876.5630
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K964514 | corpak | CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS | June 26, 1998 |
| K974570 | medigroup | PERITONEAL DIALYSIS CATHETER CONNECTOR | February 27, 1998 |
| K910787 | accurate surgical instruments | TITANIUM CONNECTOR (2 PART) | August 15, 1991 |
| K885037 | bernard j. cooney, p.a | AMUKIN 50% - AIRSPRAY(R) | October 19, 1990 |
| K874650 | quinton | PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) | December 9, 1987 |
| K872221 | gesco intl | DIALY-NATE SET & DIALY-NATE CATHETER | October 13, 1987 |
| K871730 | quinton | MODIFIED USE OF PULL-APART INTRODUCER SET | May 18, 1987 |
| K870472 | quinton | ACUTE PERITONEAL DIALYSIS KIT | February 25, 1987 |
| K860155 | medical components | PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 | February 14, 1986 |
| K854966 | thermedics | ACUTE PERITONEAL DIALYSIS CATHETERS | January 9, 1986 |
| K845041 | abbott laboratories | CAPD STAGED CONNECTOR | February 21, 1985 |
| K813336 | american pharmaseal div. ahsc | LAZARUS-NELSON PERITONEAL LAVAGE TRAY | December 18, 1981 |
| K812717 | quinton | NON-STERILE SHADOW-STRIPE CATHETER | October 19, 1981 |
| K811266 | quinton | QUINTON CATHETER FINGER GRIP | June 18, 1981 |
| K802954 | associated medical products | DRESSING CHANGE TRAY-MEDIUM | December 17, 1980 |
| K760544 | travenol laboratories | CATHETER, PERITONEAL DIALYSIS | October 20, 1976 |