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510(k) K843821

SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS by Solco Basle, Inc. — Product Code CAC

K843821 is an FDA 510(k) premarket notification submitted by Solco Basle, Inc. for the device "SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS". The FDA issued a decision of Substantially Equivalent on October 1, 1985. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Solco Basle, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1985
Date Received
September 28, 1984
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.

  • K913247 — SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM (February 25, 1993)
  • K913177 — SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM (February 25, 1993)
  • K915867 — SOLCOVAC WOUND DRAINAGE SYSTEM (August 14, 1992)
  • K896857 — SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM (April 5, 1990)
  • K896858 — SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM (April 5, 1990)
  • K896203 — SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER (February 1, 1990)
  • K883058 — SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM (October 28, 1988)
  • K872590 — SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM (September 4, 1987)
  • K872157 — HALL VEIN STRIPPER (July 7, 1987)

Other clearances for product code CAC

  • K241236 — XTRA Collection sets; XTRA Sequestration set X (August 16, 2024)
  • K240426 — Aventus Clot Management System (May 14, 2024)
  • K240584 — XTRA Autotransfusion System (with XTRA Bowl sets) (April 29, 2024)
  • K231782 — FlowSaver Blood Return System (80-101) (July 14, 2023)
  • K221483 — FlowSaver Blood Return System (February 17, 2023)
  • K221722 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) (November 15, 2022)
  • K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suc (September 3, 2021)
  • K210862 — Hemafuse System (July 29, 2021)
  • K210176 — FlowSaver Blood Filter (July 22, 2021)
  • K210089 — CATSmart, Automated Blood Processing Autotransfusion System (February 11, 2021)

FDA data resources