Home / 510(k) Clearances / K834615

510(k) K834615

TRIPLE LUMEN INFUSIONCATHETERS- by Medical Components, Inc. — Product Code JCY

K834615 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "TRIPLE LUMEN INFUSIONCATHETERS-". The FDA issued a decision of Substantially Equivalent on February 14, 1984. The device falls under product code JCY (Catheter, Infusion), a Class I device regulated under 21 CFR 878.4200. Medical Components, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1984
Date Received
December 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Infusion
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
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 JCY

  • K863982 — VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY (October 24, 1986)
  • K840324 — SILICONE SUMP DRAIN 20 & 40 FRENCH (April 25, 1984)
  • K831453 — SILCATH CENTRAL CATHETER TRAY W/18 GA (July 28, 1983)
  • K831451 — SILCATH CENTRAL CATHETER TRAY SIZE- (June 8, 1983)
  • K822096 — CHEMOTHERAPY INFUSION CATHETER (April 12, 1983)
  • K813606 — SILICONE ELASTOMER INFUSION CATHETER (January 18, 1982)
  • K791372 — JELCO & KVO CATHETER PLACEMENT UNIT (September 12, 1979)
  • K771861 — CATHETER, CEBTRAL VENOUS, 2N1501 (November 28, 1977)
  • K760760 — CATHETER, INTRAVASCULAR (ARGYLE IV SK) (December 9, 1976)
  • K760380 — INTRAVENOUS TRANSFER SET (INTRAFIX) (November 2, 1976)

FDA data resources