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510(k) K925524

CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) by Cardio Metrics, Inc. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1993
Date Received
November 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
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)

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