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510(k) K854113

CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH by American Bentley — Product Code KRI

K854113 is an FDA 510(k) premarket notification submitted by American Bentley for the device "CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH". The FDA issued a decision of Substantially Equivalent on January 8, 1986. The device falls under product code KRI (Accessory Equipment, Cardiopulmonary Bypass), a Class I device regulated under 21 CFR 870.4200. American Bentley has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1986
Date Received
October 8, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory Equipment, Cardiopulmonary Bypass
Device Class
Class I
Regulation Number
870.4200
Review Panel
CV
Submission Type

Other clearances by American Bentley

  • K872896 — UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 (February 12, 1988)
  • K873923 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER (November 6, 1987)
  • K872167 — CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 (September 1, 1987)
  • K870804 — CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 (September 1, 1987)
  • K872133 — OXYGENATOR MODEL NO. BENTLEY 5 PLUS (August 24, 1987)
  • K870911 — INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY (May 29, 1987)
  • K870269 — ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100 (March 9, 1987)
  • K863249 — OXYGENATOR MODEL NO. BENTLEY-10 PLUS (October 20, 1986)
  • K861641 — HEPARIN-COATED EXTRACORPOREAL CIRCUITS (September 29, 1986)
  • K862549 — ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE (July 15, 1986)

Other clearances for product code KRI

  • K020365 — 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE (May 3, 2002)
  • K992635 — INTERFACE MODULE IDDD (December 20, 1999)
  • K990512 — STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS (November 23, 1999)
  • K934782 — AMMEX TUBING ORGANIZER (November 18, 1993)
  • K926233 — CARDIO2 CYCLE (June 4, 1993)
  • K922404 — TUBE GRIP (November 23, 1992)
  • K892856 — NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (November 8, 1989)
  • K884893 — CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 (January 30, 1989)
  • K884640 — CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (January 24, 1989)
  • K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (February 2, 1988)

FDA data resources