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510(k) K020365

3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE by 3t Medical Systems, LLC — Product Code KRI

K020365 is an FDA 510(k) premarket notification submitted by 3t Medical Systems, LLC for the device "3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE". The FDA issued a decision of Substantially Equivalent on May 3, 2002. The device falls under product code KRI (Accessory Equipment, Cardiopulmonary Bypass), a Class I device regulated under 21 CFR 870.4200. 3t Medical Systems, LLC has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2002
Date Received
February 4, 2002
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 3t Medical Systems, LLC

  • K072697 — 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES (December 20, 2007)
  • K022287 — 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS (September 23, 2002)
  • K020768 — 3T VESSEL CANNULAS (August 23, 2002)
  • K001245 — 3T L. V. CONTROL VALVE (August 15, 2001)

Other clearances for product code KRI

  • 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)
  • K874925 — CPE 2000 CARDIO PULMONARY ERGOMETER (January 19, 1988)

FDA data resources