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510(k) K872364

HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 by Travenol Laboratories, S.A. — Product Code FII

K872364 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309". The FDA issued a decision of Substantially Equivalent on October 13, 1987. The device falls under product code FII (System, Dialysate Delivery, Sealed), a Class II device regulated under 21 CFR 876.5860. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1987
Date Received
June 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Sealed
Device Class
Class II
Regulation Number
876.5860
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)
  • 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)
  • K870169 — CAPILLARY FLOW DIALYZERS (April 6, 1987)

Other clearances for product code FII

  • K030470 — NXSTAGE SYSTEM ONE (July 7, 2003)
  • K881270 — GAMBRO MULTIPURPOSE SYSTEM MPS-10 (August 24, 1988)
  • K862716 — HEMOFILTRATION SYSTEM 10 (September 9, 1986)
  • K822386 — COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA (October 6, 1982)

FDA data resources