Product code LFK— Gastroenterology, Urology
ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7
- Classification name
- Catheter, Femoral
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code LFK
FDA has cleared devices under product code LFK between 1982 and 1997, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1997
- 1992
- 1989
- 1988
- 1987
- 1986
- 1983
- 1982
Top applicants under product code LFK
Recent clearances under product code LFK
- K971897 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)
- K914936 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET
- K915215 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS
- K891763 — FC-100 FEMORAL CATHETER
- K891764 — FC-101 FEMORAL CATHETER GUIDE WIRE
- K890717 — MODIFICATION HEMOFILTRATION CATHETER HF-100
- K880775 — CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY
- K882466 — VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER
- K865096 — NEW SECOND FRENCH SIZE MAHURKAR CATHETER
- K863218 — CYTOSTATIC FILTRATION SET
- K862771 — MEDCOMP C.A.V.H. CATHETER
- K860810 — MEDCOMP'S FEMORAL VEIN CATHETERS
- K854612 — ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7
- K831828 — TEFLON FEMORAL CATHETER MWI 100,10 &
- K830674 — MAHURKAR FEMORAL CATHETER
- K820237 — COBE ACUFLEX FSN, #15-208
Data sourced from openFDA. This site is unofficial and independent of the FDA.