Panels › Gastroenterology, Urology › Product code FKO · Class 2
Catheter, Peritoneal Dialysis, Single Use
Regulation 876.5630
0510(k)s in 12 months (16 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FKO
| Company | 510(k)s | Recalls |
|---|---|---|
| Quinton, Inc. | 5 | 0 |
| Abbott Laboratories | 1 | 0 |
| Accurate Surgical Instruments Co. | 1 | 0 |
| American Pharmaseal Div. Ahsc | 1 | 0 |
| Associated Medical Products Co. | 1 | 0 |
| Bernard J. Cooney, P.A. | 1 | 0 |
| Corpak, Inc. | 1 | 0 |
| Gesco Intl., Inc. | 1 | 0 |
| Medical Components, Inc. | 1 | 0 |
| Medigroup, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 26, 1998 | K964514 | CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS Corpak, Inc. | FKO |
| Feb 27, 1998 | K974570 | PERITONEAL DIALYSIS CATHETER CONNECTOR Medigroup, Inc. | FKO |
| Aug 15, 1991 | K910787 | TITANIUM CONNECTOR (2 PART) Accurate Surgical Instruments Co., CA | FKO |
| Oct 19, 1990 | K885037 | AMUKIN 50% - AIRSPRAY(R) Bernard J. Cooney, P.A. | FKO |
| Dec 9, 1987 | K874650 | PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) Quinton, Inc. | FKO |
| Oct 13, 1987 | K872221 | DIALY-NATE SET & DIALY-NATE CATHETER Gesco Intl., Inc. | FKO |
| May 18, 1987 | K871730 | MODIFIED USE OF PULL-APART INTRODUCER SET Quinton, Inc. | FKO |
| Feb 25, 1987 | K870472 | ACUTE PERITONEAL DIALYSIS KIT Quinton, Inc. | FKO |
| Feb 14, 1986 | K860155 | PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 Medical Components, Inc. | FKO |
| Jan 9, 1986 | K854966 | ACUTE PERITONEAL DIALYSIS CATHETERS Thermedics, Inc. | FKO |
| Feb 21, 1985 | K845041 | CAPD STAGED CONNECTOR Abbott Laboratories | FKO |
| Dec 18, 1981 | K813336 | LAZARUS-NELSON PERITONEAL LAVAGE TRAY American Pharmaseal Div. Ahsc | FKO |
| Oct 19, 1981 | K812717 | NON-STERILE SHADOW-STRIPE CATHETER Quinton, Inc. | FKO |
| Jun 18, 1981 | K811266 | QUINTON CATHETER FINGER GRIP Quinton, Inc. | FKO |
| Dec 17, 1980 | K802954 | DRESSING CHANGE TRAY-MEDIUM Associated Medical Products Co. | FKO |
| Oct 20, 1976 | K760544 | CATHETER, PERITONEAL DIALYSIS Travenol Laboratories, S.A. | FKO |
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