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510(k) K790223

DIALYZER, CD-800 COIL by Travenol Laboratories, S.A. — Product Code FHS

K790223 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "DIALYZER, CD-800 COIL". The FDA issued a decision of Substantially Equivalent on Mar 26, 1979. 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 205 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 26, 1979
Date Received
Feb 2, 1979
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
510(k)

Other clearances by Travenol Laboratories, S.A.

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

Other clearances for product code FHS

  • K812811 — MICROCOIL 80 DIALYZER (Dec 3, 1981)
  • K811974 — MICROCOIL 150 DIALYZER (Sep 16, 1981)
  • K801634 — THE VITA 2 DISPOSABLE DIALYZER (Dec 17, 1980)
  • K800723 — MICRO-COIL 100 COIL DIALYZER (May 14, 1980)
  • K800174 — GAMBRO LUNDIA COIL DIALYZER (Feb 13, 1980)
  • K781102 — DIALYZER, DISP., COIL, LUNDIA (Oct 17, 1978)
  • K771349 — MODIFICATION TO KIDNEY DIALYZER (Aug 2, 1977)
  • K770735 — DIALYZER, COIL, CD, LSA, 5M1765 (May 10, 1977)
  • K761358 — COIL DIALYZER MODEL ALT 140 (Jan 10, 1977)
  • K760702 — ERI-FLO 900 DIALYZER (Nov 19, 1976)

FDA data resources

Source: FDA 510(k) database entry for K790223. Report a data issue: hello@regdatalab.com.