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510(k) K791372

JELCO & KVO CATHETER PLACEMENT UNIT by Jelco Laboratories — Product Code JCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1979
Date Received
July 24, 1979
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 Jelco Laboratories

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  • K790967 — CATHETER METAL HUB/RADIOPAQUE (June 27, 1979)
  • K790968 — CATHETER METAL HUB/NONRADIOPAQUE (June 11, 1979)
  • K790471 — JELCO* DISC FILTER-0.2 MICRON (April 30, 1979)
  • K790186 — PROTECTIVSTABILIZER (February 26, 1979)
  • K790107 — CATHETER TUBING MODIFICATION (February 1, 1979)
  • K790079 — NEEDLE, BLOOD COLLECTING (February 1, 1979)
  • K781857 — TRAY, ARTERIAL BLOOD GAS SAMPLING (December 11, 1978)
  • K780896 — NEEDLES, DESIGN CHANGE, IV CATHETERS (August 23, 1978)
  • K780519 — FILTER TUBE (May 9, 1978)

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  • K834615 — TRIPLE LUMEN INFUSIONCATHETERS- (February 14, 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)
  • K771861 — CATHETER, CEBTRAL VENOUS, 2N1501 (November 28, 1977)
  • K760760 — CATHETER, INTRAVASCULAR (ARGYLE IV SK) (December 9, 1976)
  • K760381 — BLOOD TRANSFUSION SET (SANGOFIX) (November 2, 1976)