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510(k) K842391

ACR 2500 CARDIOTOMY RESERVOIR FILTER by Electromedics, Inc. — Product Code DTN

K842391 is an FDA 510(k) premarket notification submitted by Electromedics, Inc. for the device "ACR 2500 CARDIOTOMY RESERVOIR FILTER". The FDA issued a decision of Substantially Equivalent on May 21, 1985. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Electromedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1985
Date Received
June 18, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

Other clearances by Electromedics, Inc.

  • K934964 — ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR (March 7, 1994)
  • K933832 — ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR (January 28, 1994)
  • K934355 — ELECTROMEDICS BLOOD HEAT EXCHANGER (December 3, 1993)
  • K930154 — EL2-SERIES BLOOD COLLECTION REERVOIR (July 1, 1993)
  • K926250 — ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR (February 19, 1993)
  • K925412 — ELECTROMEDICS TISSUE TRAP/ #TT280 (February 5, 1993)
  • K915737 — AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR (September 3, 1992)
  • K910238 — PORTABLE AUTO TRANSFUSION SYSTEM 500 (June 19, 1991)
  • K910935 — MODIFIED PYROGEN TESTING (May 16, 1991)
  • K902723 — ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 (December 13, 1990)

Other clearances for product code DTN

  • K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs (December 22, 2025)
  • K241206 — Quantum Perfusion Hybrid System (July 18, 2024)
  • K241053 — MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous (May 15, 2024)
  • K223361 — BMR 1900 PHISIO (June 10, 2023)
  • K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface (March 17, 2017)
  • K161733 — INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C (March 8, 2017)
  • K153143 — Capiox Advance Hardshell Reservoir (December 2, 2015)
  • K151110 — Intersept Filtered Cardiotomy Reservoir (May 27, 2015)
  • K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDI (July 7, 2014)
  • K141233 — AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSU (June 12, 2014)

FDA data resources