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510(k) K860810

MEDCOMP'S FEMORAL VEIN CATHETERS by Medical Components, Inc. — Product Code LFK

K860810 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "MEDCOMP'S FEMORAL VEIN CATHETERS". The FDA issued a decision of Substantially Equivalent on April 8, 1986. The device falls under product code LFK (Catheter, Femoral), a Class II device regulated under 21 CFR 876.5540. Medical Components, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1986
Date Received
March 4, 1986
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 Medical Components, Inc.

  • K250836 — 14F Duo-Flow® Side X Side Double Lumen Catheter (August 12, 2025)
  • K141633 — PRO-PICC WITH VALVE TECHNOLOGY (September 29, 2014)
  • K132880 — MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE (January 8, 2014)
  • K131687 — 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET (August 16, 2013)
  • K130687 — 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER (August 15, 2013)
  • K130923 — 5F DIGNITY CT TITANIUM PORT (July 31, 2013)
  • K124046 — VALVED TEARAWAY INTRODUCER GENERATION II (June 3, 2013)
  • K123617 — 3F PRO-PICC (May 15, 2013)
  • K122423 — VASU-PICC (December 12, 2012)
  • K121848 — SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT (September 21, 2012)

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)
  • K890717 — MODIFICATION HEMOFILTRATION CATHETER HF-100 (April 5, 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)

FDA data resources