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510(k) K982650

AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) by Dideco S.P.A. — Product Code CAC

K982650 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)". The FDA issued a decision of Substantially Equivalent on Dec 16, 1998. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Dideco S.P.A. has 32 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 16, 1998
Date Received
Jul 30, 1998
Clearance Type
Abbreviated
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
510(k)

Other clearances by Dideco S.P.A.

  • K052717 — D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER (Oct 20, 2005)
  • K051232 — D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O… (May 20, 2005)
  • K050890 — ECC.O SYSTEM (May 5, 2005)
  • K050447 — PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR (Mar 8, 2005)
  • K043323 — D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY… (Feb 1, 2005)
  • K041061 — D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS (May 6, 2004)
  • K033323 — D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT… (Jan 13, 2004)
  • K033987 — D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS (Jan 8, 2004)
  • K033714 — MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE… (Dec 11, 2003)
  • K032040 — IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP… (Jul 9, 2003)

Other clearances for product code CAC

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

FDA data resources

Source: FDA 510(k) database entry for K982650. Report a data issue: hello@regdatalab.com.