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510(k) K770735

DIALYZER, COIL, CD, LSA, 5M1765 by Travenol Laboratories, S.A. — Product Code FHS

K770735 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "DIALYZER, COIL, CD, LSA, 5M1765". The FDA issued a decision of Substantially Equivalent on May 10, 1977. The device falls under product code FHS (Dialyzer, Single Coil), a Class II device regulated under 21 CFR 876.5820. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1977
Date Received
April 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Single Coil
Device Class
Class II
Regulation Number
876.5820
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 FHS

  • K812811 — MICROCOIL 80 DIALYZER (December 3, 1981)
  • K811974 — MICROCOIL 150 DIALYZER (September 16, 1981)
  • K801634 — THE VITA 2 DISPOSABLE DIALYZER (December 17, 1980)
  • K800723 — MICRO-COIL 100 COIL DIALYZER (May 14, 1980)
  • K800174 — GAMBRO LUNDIA COIL DIALYZER (February 13, 1980)
  • K790223 — DIALYZER, CD-800 COIL (March 26, 1979)
  • K781102 — DIALYZER, DISP., COIL, LUNDIA (October 17, 1978)
  • K771349 — MODIFICATION TO KIDNEY DIALYZER (August 2, 1977)
  • K761358 — COIL DIALYZER MODEL ALT 140 (January 10, 1977)
  • K760702 — ERI-FLO 900 DIALYZER (November 19, 1976)

FDA data resources