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510(k) K830909

MIKRO-TIP CATH. PRESSURE TRANSDUCER by Millar Instruments, Inc. — Product Code KRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1983
Date Received
March 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Thermodilution
Device Class
Class II
Regulation Number
870.1915
Review Panel
CV
Submission Type

Other clearances by Millar Instruments, Inc.

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  • K993694 — MIKRO-TIP ANGIOGRAPHIC CATHETER (March 1, 2000)
  • K952773 — MIKRO-TIP ANGIOGRAPHIC CATHETER (November 7, 1995)
  • K935166 — FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER (August 5, 1994)
  • K915775 — MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN (April 20, 1992)
  • K896264 — MILLAR MIKRO-TIP DOPPLER CATHETER (January 24, 1990)
  • K895721 — MILLAR MIKRO-TIP PULSE TRANSDUCER (December 7, 1989)
  • K883651 — MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER (November 18, 1988)

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  • K020587 — PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV (May 23, 2002)
  • K991886 — PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSO (May 11, 2000)
  • K936182 — CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT (March 25, 1994)
  • K915627 — PACEVIEW (March 27, 1992)
  • K912172 — SAFEWEDGE(TM) RELIEF VALVE DEVICE (September 27, 1991)
  • K902627 — INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. (February 25, 1991)
  • K900710 — INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER (October 19, 1990)