510(k) K890717
- Device
- MODIFICATION HEMOFILTRATION CATHETER HF-100
- Applicant
- VAS-CATH, INC.
- 510(k) number
- K890717
- Product code
- LFK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-04-05
- Date received
- 1989-02-13
- Regulation
- 876.5540
- Classification name
- Catheter, Femoral
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BETTY-ANN BUTCHER
- Address
- 2380 Tedlo St. Mississauga, Ontario CA L5A 3V3 L5A 3V3
FDA Registration Numbers#
- 2518902
- 3003915875
- 1722746
- 3005987240
- 2527072
- 2030624
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LFK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971897 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) | Medron, Inc. | 1997-10-21 |
| K914936 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET | Akcess Medical Products, Inc. | 1992-04-23 |
| K915215 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS | Akcess Medical Products, Inc. | 1992-03-27 |
| K891763 | FC-100 FEMORAL CATHETER | Akcess Medical Products, Inc. | 1989-04-07 |
| K891764 | FC-101 FEMORAL CATHETER GUIDE WIRE | Akcess Medical Products, Inc. | 1989-04-07 |
| K880775 | CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY | Medsurg Industries, Inc. | 1988-07-25 |
| K882466 | VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER | Vas-Cath, Inc. | 1988-07-13 |
| K865096 | NEW SECOND FRENCH SIZE MAHURKAR CATHETER | Quinton, Inc. | 1987-02-18 |
| K863218 | CYTOSTATIC FILTRATION SET | Meadox Surgimed, Inc. | 1987-02-12 |
| K862771 | MEDCOMP C.A.V.H. CATHETER | Medical Components, Inc. | 1986-08-06 |
| K860810 | MEDCOMP'S FEMORAL VEIN CATHETERS | Medical Components, Inc. | 1986-04-08 |
| K854612 | ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 | Med-West, Inc. | 1986-01-03 |
| K831828 | TEFLON FEMORAL CATHETER MWI 100,10 & | Med-West, Inc. | 1983-07-07 |
| K830674 | MAHURKAR FEMORAL CATHETER | Quinton, Inc. | 1983-05-18 |
| K820237 | COBE ACUFLEX FSN, #15-208 | Cobe Laboratories, Inc. | 1982-03-10 |
Legacy Summary#
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FDA Review#
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