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510(k) K883058

SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM by Solco Basle, Inc. — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1988
Date Received
July 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Autotransfusion
Device Class
Class II
Regulation Number
868.5830
Review Panel
CV
Submission Type

Other clearances by Solco Basle, Inc.

  • K913177 — SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM (February 25, 1993)
  • K913247 — SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM (February 25, 1993)
  • K915867 — SOLCOVAC WOUND DRAINAGE SYSTEM (August 14, 1992)
  • K896858 — SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM (April 5, 1990)
  • K896857 — SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM (April 5, 1990)
  • K896203 — SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER (February 1, 1990)
  • K872590 — SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM (September 4, 1987)
  • K872157 — HALL VEIN STRIPPER (July 7, 1987)
  • K843821 — SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS (October 1, 1985)

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  • K210862 — Hemafuse System (July 29, 2021)
  • K210176 — FlowSaver Blood Filter (July 22, 2021)
  • K210089 — CATSmart, Automated Blood Processing Autotransfusion System (February 11, 2021)