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510(k) K860298

STABLELINE by Cardio Metrics, Inc. — Product Code KRI

K860298 is an FDA 510(k) premarket notification submitted by Cardio Metrics, Inc. for the device "STABLELINE". The FDA issued a decision of Substantially Equivalent on April 2, 1986. The device falls under product code KRI (Accessory Equipment, Cardiopulmonary Bypass), a Class I device regulated under 21 CFR 870.4200. Cardio Metrics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1986
Date Received
January 28, 1986
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 Cardio Metrics, Inc.

  • K972762 — CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES (October 14, 1997)
  • K965140 — CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM (August 18, 1997)
  • K951567 — CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE (October 25, 1996)
  • K961777 — ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 (July 31, 1996)
  • K955551 — CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404 (February 28, 1996)
  • K954913 — CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION) (November 7, 1995)
  • K952562 — CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (August 29, 1995)
  • K943022 — CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE (September 19, 1994)
  • K940984 — CARDIOMETRICS DUALFLOW SWITCH BOX (August 18, 1994)
  • K933320 — CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT (August 17, 1994)

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