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510(k) K936220

DIDECO VACUUM PUMP by Dideco — Product Code CAC

K936220 is an FDA 510(k) premarket notification submitted by Dideco for the device "DIDECO VACUUM PUMP". The FDA issued a decision of Substantially Equivalent on Jan 27, 1995. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Dideco has 32 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 27, 1995
Date Received
Dec 28, 1993
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
510(k)

Other clearances by Dideco

  • 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 K936220. Report a data issue: hello@regdatalab.com.