510(k) K974570
- Device
- PERITONEAL DIALYSIS CATHETER CONNECTOR
- Applicant
- MEDIGROUP, INC.
- 510(k) number
- K974570
- Product code
- FKO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-02-27
- Date received
- 1997-12-08
- Regulation
- 876.5630
- Classification name
- Catheter, Peritoneal Dialysis, Single Use
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN NAVIS
- Address
- 615 Enterprise St. Aurora IL US 60504 60504
FDA Registration Numbers#
- 1721676
- 3001239013
- 3009211636
- 1718873
- 2011171
- 3015309643
- 9610849
- 3005987240
- 1319639
- 1282497
- 3030574705
- 3012536737
- 1724474
- 3033589330
- 9616675
- 3015225571
- 1721504
- 3006950086
- 1423507
Source Documents#
Other 510(k) Records For Product Code FKO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964514 | CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS | Corpak, Inc. | 1998-06-26 |
| K910787 | TITANIUM CONNECTOR (2 PART) | Accurate Surgical Instruments Co. | 1991-08-15 |
| K885037 | AMUKIN 50% - AIRSPRAY(R) | Bernard J. Cooney, P.A. | 1990-10-19 |
| K874650 | PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) | Quinton, Inc. | 1987-12-09 |
| K872221 | DIALY-NATE SET & DIALY-NATE CATHETER | Gesco Intl., Inc. | 1987-10-13 |
| K871730 | MODIFIED USE OF PULL-APART INTRODUCER SET | Quinton, Inc. | 1987-05-18 |
| K870472 | ACUTE PERITONEAL DIALYSIS KIT | Quinton, Inc. | 1987-02-25 |
| K860155 | PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 | Medical Components, Inc. | 1986-02-14 |
| K854966 | ACUTE PERITONEAL DIALYSIS CATHETERS | Thermedics, Inc. | 1986-01-09 |
| K845041 | CAPD STAGED CONNECTOR | Abbott Laboratories | 1985-02-21 |
| K813336 | LAZARUS-NELSON PERITONEAL LAVAGE TRAY | American Pharmaseal Div. Ahsc | 1981-12-18 |
| K812717 | NON-STERILE SHADOW-STRIPE CATHETER | Quinton, Inc. | 1981-10-19 |
| K811266 | QUINTON CATHETER FINGER GRIP | Quinton, Inc. | 1981-06-18 |
| K802954 | DRESSING CHANGE TRAY-MEDIUM | Associated Medical Products Co. | 1980-12-17 |
| K760544 | CATHETER, PERITONEAL DIALYSIS | Travenol Laboratories, S.A. | 1976-10-20 |
Legacy Summary#
summary
FDA Review#
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