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510(k) K112323

CARDIA-CATH by Millar Instruments, Inc. — Product Code DXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2011
Date Received
August 12, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Pressure, Catheter Tip
Device Class
Class II
Regulation Number
870.2870
Review Panel
CV
Submission Type

Other clearances by Millar Instruments, Inc.

  • K093111 — MIKRO-CATH, MODEL 825-0101 (January 5, 2010)
  • K013205 — MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 (July 2, 2002)
  • 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)
  • K860766 — MILLAR PULSED DOPPLER VELOCIMETER (July 29, 1986)

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