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510(k) K812622

HEMODIALYSIS VENOUS & ARTERIAL SET by Amisco Trading Corp. — Product Code FKH

K812622 is an FDA 510(k) premarket notification submitted by Amisco Trading Corp. for the device "HEMODIALYSIS VENOUS & ARTERIAL SET". The FDA issued a decision of Substantially Equivalent on September 24, 1981. The device falls under product code FKH (Solution-Test Standard-Conductivity, Dialysis), a Class II device regulated under 21 CFR 876.5820. Amisco Trading Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1981
Date Received
September 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution-Test Standard-Conductivity, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Amisco Trading Corp.

  • K812621 — DELTA-A.V. FISTULA CANNULATION SET (September 24, 1981)

Other clearances for product code FKH

  • K191496 — TDS Standard Solution (August 5, 2019)
  • K130100 — COMINED STANDARD SOLUTION (April 18, 2013)
  • K041636 — H&S-CONDUCTIVITY STANDARD SOLUTION (July 2, 2004)
  • K033330 — CONDUCTIVITY/TDS CALIBRATOR SOLUTION (February 27, 2004)
  • K032075 — CONDUCTIVITY STANDARD SOLUTION-METERCARE (September 17, 2003)
  • K863824 — SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. (October 24, 1986)
  • K851362 — STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF (June 12, 1985)

FDA data resources