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510(k) K802830

MILLAR MIKRO-TIP CATHETER PHONOTRANS by Millar Instruments, Inc. — Product Code DXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1980
Date Received
November 10, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Phonocatheter, Intracavitary
Device Class
Class II
Regulation Number
870.1270
Review Panel
CV
Submission Type

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  • 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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  • K800179 — INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR (February 11, 1980)