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510(k) K890717

MODIFICATION HEMOFILTRATION CATHETER HF-100 by Vas-Cath, Inc. — Product Code LFK

K890717 is an FDA 510(k) premarket notification submitted by Vas-Cath, Inc. for the device "MODIFICATION HEMOFILTRATION CATHETER HF-100". The FDA issued a decision of Substantially Equivalent on April 5, 1989. The device falls under product code LFK (Catheter, Femoral), a Class II device regulated under 21 CFR 876.5540. Vas-Cath, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1989
Date Received
February 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Femoral
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Vas-Cath, Inc.

  • K973013 — OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER (June 19, 1998)
  • K965178 — NIAGARA DUAL LUMEN CATHETER (August 19, 1997)
  • K964881 — ULTRAVERSE PTA CATHETER (May 28, 1997)
  • K970725 — OPTI-PLAST XL 5.5 F PTA CATHETER (May 9, 1997)
  • K941706 — OPTI-PLAST ANGIOPLASTY CATHETER (October 18, 1994)
  • K925485 — VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER (March 10, 1994)
  • K933483 — OPTI-PLAST 5F PTA CATHETERS (September 24, 1993)
  • K914162 — VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS (July 1, 1993)
  • K914210 — VAS-CATH DUALATOR(TM) VESSEL DILATOR (July 1, 1993)
  • K914976 — OPTI-PLAST 5F PTA CATHETERS, MODIFICATION (January 27, 1992)

Other clearances for product code LFK

  • K971897 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) (October 21, 1997)
  • K914936 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET (April 23, 1992)
  • K915215 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS (March 27, 1992)
  • K891764 — FC-101 FEMORAL CATHETER GUIDE WIRE (April 7, 1989)
  • K891763 — FC-100 FEMORAL CATHETER (April 7, 1989)
  • K880775 — CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY (July 25, 1988)
  • K882466 — VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER (July 13, 1988)
  • K865096 — NEW SECOND FRENCH SIZE MAHURKAR CATHETER (February 18, 1987)
  • K863218 — CYTOSTATIC FILTRATION SET (February 12, 1987)
  • K862771 — MEDCOMP C.A.V.H. CATHETER (August 6, 1986)

FDA data resources