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510(k) K760760

CATHETER, INTRAVASCULAR (ARGYLE IV SK) by Sherwood Medical Industries — Product Code JCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1976
Date Received
October 4, 1976
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

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  • K790196 — MONOJECT ARTERIAL BLOOD SAMPLING DEVICE (March 13, 1979)
  • K790197 — REAGENT KIT, LANCER GLUCOSE (March 12, 1979)
  • K781459 — MONOJECT SCALE MAGNIFIER (October 24, 1978)
  • K781060 — MONOJECT ENDOSSEOUS DENTAL IMPLANT (August 14, 1978)

Other clearances for product code JCY

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  • 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)
  • K760391 — CATHETER, VEIN (BRAUNULA) (November 2, 1976)