FDA Product Code
FDA Product Code FKO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5630
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K964514 | CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS | Corpak, Inc. | 1998-06-26 | Traditional | PDF ↗ |
| K974570 | PERITONEAL DIALYSIS CATHETER CONNECTOR | Medigroup, Inc. | 1998-02-27 | Traditional | PDF ↗ |
| K910787 | TITANIUM CONNECTOR (2 PART) | Accurate Surgical Instruments Co. | 1991-08-15 | Traditional | PDF ↗ |
| K885037 | AMUKIN 50% - AIRSPRAY(R) | Bernard J. Cooney, P.A. | 1990-10-19 | Traditional | PDF ↗ |
| K874650 | PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) | Quinton, Inc. | 1987-12-09 | Traditional | PDF ↗ |
| K872221 | DIALY-NATE SET & DIALY-NATE CATHETER | Gesco Intl., Inc. | 1987-10-13 | Traditional | PDF ↗ |
| K871730 | MODIFIED USE OF PULL-APART INTRODUCER SET | Quinton, Inc. | 1987-05-18 | Traditional | PDF ↗ |
| K870472 | ACUTE PERITONEAL DIALYSIS KIT | Quinton, Inc. | 1987-02-25 | Traditional | PDF ↗ |
| K860155 | PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 | Medical Components, Inc. | 1986-02-14 | Traditional | PDF ↗ |
| K854966 | ACUTE PERITONEAL DIALYSIS CATHETERS | Thermedics, Inc. | 1986-01-09 | Traditional | PDF ↗ |
| K845041 | CAPD STAGED CONNECTOR | Abbott Laboratories | 1985-02-21 | Traditional | PDF ↗ |
| K813336 | LAZARUS-NELSON PERITONEAL LAVAGE TRAY | American Pharmaseal Div. Ahsc | 1981-12-18 | Traditional | PDF ↗ |
| K812717 | NON-STERILE SHADOW-STRIPE CATHETER | Quinton, Inc. | 1981-10-19 | Traditional | PDF ↗ |
| K811266 | QUINTON CATHETER FINGER GRIP | Quinton, Inc. | 1981-06-18 | Traditional | PDF ↗ |
| K802954 | DRESSING CHANGE TRAY-MEDIUM | Associated Medical Products Co. | 1980-12-17 | Traditional | PDF ↗ |
| K760544 | CATHETER, PERITONEAL DIALYSIS | Travenol Laboratories, S.A. | 1976-10-20 | Traditional | PDF ↗ |
Product code FKO · Class II · Gastroenterology, Urology. Data: openFDA.