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510(k) K863297

MODIFICATION'S TO TORAY'S B-2 SERIES by National Medical Care, Medical Products Div., Inc. — Product Code FJT

K863297 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "MODIFICATION'S TO TORAY'S B-2 SERIES". The FDA issued a decision of Substantially Equivalent on September 25, 1986. The device falls under product code FJT (Intracatheter, Dialysis), a Class II device regulated under 21 CFR 876.5820. National Medical Care, Medical Products Div., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1986
Date Received
August 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intracatheter, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by National Medical Care, Medical Products Div., Inc.

  • K962081 — COMBILINES HEMODIALYSIS BLOOD TUBING SET (November 1, 1996)
  • K941757 — FORMALIN REUSE CART (January 22, 1996)
  • K952343 — FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER (December 22, 1995)
  • K930843 — RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 (August 31, 1994)
  • K914790 — HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R (March 5, 1993)
  • K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (September 21, 1992)
  • K920697 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP (September 21, 1992)
  • K920586 — DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET (September 21, 1992)
  • K920797 — HEMODIALYSIS BLOOD TUBING SET (September 21, 1992)
  • K920029 — DEXTROLYTE II CAPD TRNSFER SET (September 21, 1992)

Other clearances for product code FJT

  • K772146 — CATHETER, VEIN, FEMORAL, SF 10 (November 29, 1977)
  • K772148 — CATHETER, FEMORAL VEIN, SF 6 (November 29, 1977)
  • K770047 — DNC 151 VINCA-FLO (January 14, 1977)
  • K760781 — TRIEX-1 HOLLOW FIBER DIALYZER (December 6, 1976)

FDA data resources