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510(k) K904515

IMPRAFLO 3500 SERIES by Impra, Inc. — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1990
Date Received
October 3, 1990
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 Impra, Inc.

  • K004012 — IMPRA CARBOFLO EPTFE VASCULAR GRAFTS (May 14, 2001)
  • K004011 — IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS (March 27, 2001)
  • K991027 — BI-DIRECTIONAL TUNNELER (April 22, 1999)
  • K983769 — DISTAFLO BYPASS GRAFT (December 15, 1998)
  • K983861 — DISTAFLO BYPASS GRAFT (November 24, 1998)
  • K983064 — IMPRA HIGH POROSITY GRAFT (November 19, 1998)
  • K981079 — VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (May 7, 1998)
  • K981076 — VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (May 7, 1998)
  • K971192 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (April 15, 1997)
  • K964877 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (March 20, 1997)

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)