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510(k) K852736

BAYLOR RAPID AUTOTRANSFUSION SYSTEM by Cardio Systems, Inc. — Product Code CAC

K852736 is an FDA 510(k) premarket notification submitted by Cardio Systems, Inc. for the device "BAYLOR RAPID AUTOTRANSFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 18, 1985. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Cardio Systems, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1985
Date Received
May 8, 1985
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 Cardio Systems, Inc.

  • K131092 — STEALTH 360 ORBITAL PAD SYSTEM (June 24, 2013)
  • K081944 — MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM (August 14, 2008)
  • K972022 — ZAK-2000 (January 22, 1998)
  • K934689 — LOW AIR LOSS MATTRESS, MODIFICATION (February 2, 1994)
  • K921500 — CENTRI-SAFE(TM) VALVE (September 15, 1992)
  • K882177 — ADD-ON TO CRITICAL PATIENT CARE BED (December 1, 1988)
  • K792151 — OXYGENATOR GAS LINE FILTER (November 13, 1979)
  • K792152 — CARDIOPLEGIA SOLUTION ADMIN. SET (November 13, 1979)

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