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510(k) K770137

NEGATIVE PRESSURE ADAPTER 5M1350 by Travenol Laboratories, S.A. — Product Code FIL

K770137 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "NEGATIVE PRESSURE ADAPTER 5M1350". The FDA issued a decision of Substantially Equivalent on February 1, 1977. The device falls under product code FIL (System, Dialysate Delivery, Single Pass), 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
February 1, 1977
Date Received
January 24, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Single Pass
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 FIL

  • K011741 — CRIT-LINE MONITOR III TQA (CLM TQA) (July 23, 2002)
  • K901038 — SPS 550-IPS (INTEGRATED PATIENT STATION) (April 19, 1990)
  • K890329 — FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM (May 11, 1989)
  • K790824 — REPGREEN ULTRAFILTRATION MONITOR (June 27, 1979)
  • K781633 — ULTRAFILTRATION SCALE (December 7, 1978)
  • K771875 — ULTRAFILTRATION MONITOR 5M9034 (November 30, 1977)
  • K771227 — AK-10 (August 2, 1977)

FDA data resources