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510(k) K822395

CF 1211 CAPILLARY FLOW DIALYZER CODE by Travenol Laboratories, S.A. — Product Code FJH

K822395 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "CF 1211 CAPILLARY FLOW DIALYZER CODE". The FDA issued a decision of Substantially Equivalent on August 12, 1982. The device falls under product code FJH (Dialyzer, Disposable), a Class II device regulated under 21 CFR 876.5830. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1982
Date Received
August 11, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Disposable
Device Class
Class II
Regulation Number
876.5830
Review Panel
GU
Submission Type

Other clearances by Travenol Laboratories, S.A.

  • K874181 — BAXTER BEDSIDE SYSTEM (February 22, 1988)
  • K873894 — CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE (November 5, 1987)
  • K873873 — RESUBMITTED MICRON TRANSFUSION FILTER (October 22, 1987)
  • K873984 — AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) (October 20, 1987)
  • K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (October 13, 1987)
  • K872652 — UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM (September 30, 1987)
  • K870801 — FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD (September 4, 1987)
  • K871908 — IV ADMINISTRATION SET (July 27, 1987)
  • K871471 — CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 (June 12, 1987)
  • K865029 — CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER (April 17, 1987)

Other clearances for product code FJH

  • K920697 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP (September 21, 1992)
  • K861646 — BIO-CARB D16000, D16001, AND D17000 (August 7, 1986)
  • K852764 — IDECAP DIALYZER (September 20, 1985)

FDA data resources