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510(k) K780189

PLATELET ROTATOR by Travenol Laboratories, S.A. — Product Code KSQ

K780189 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "PLATELET ROTATOR". The FDA issued a decision of Substantially Equivalent on March 30, 1978. The device falls under product code KSQ (Device, Blood Mixing And Blood Weighing), a Class I device regulated under 21 CFR 864.9195. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1978
Date Received
February 6, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Blood Mixing And Blood Weighing
Device Class
Class I
Regulation Number
864.9195
Review Panel
HE
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 KSQ

  • K842746 — HYCEL ROTOR-MIXER AND/OR MULTI (August 17, 1984)
  • K820712 — SEPCOR UNIT COLLECTION MONITOR (May 7, 1982)
  • K812533 — PLATELET AGITATOR (September 29, 1981)
  • K810617 — MOBILE MATIC AUTOMATIC DONOR SCALE (April 7, 1981)
  • K802608 — HEMATIC BLOOD MIXER (December 11, 1980)
  • K800104 — ROYCO MODEL 951 CELL MIXER (February 6, 1980)
  • K760743 — DONORMATIC (BLOOD COLLECTION DEVICE) (December 6, 1976)

FDA data resources