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510(k) K860526

NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH by Nova Medical Specialties — Product Code DXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1986
Date Received
February 11, 1986
Clearance Type
Traditional
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 Nova Medical Specialties

  • K872770 — DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. (October 15, 1987)
  • K853625 — NOVA ARTERIAL EMBOLECTOMY CATHETER (January 15, 1986)
  • K840009 — NOVA 12 CARDIAC OUTPUT COMPUTER (August 22, 1984)
  • K841639 — NOVA BALLOON THERMODILUTION CATH. (August 12, 1984)
  • K841640 — NOVA BALLOON THERMODILUTION INFUSION (August 12, 1984)
  • K834037 — HEPARIN COATED BALLOON THERMODILU (January 10, 1984)
  • K834036 — HEPARIN COATED BALLOON THERMODILU (January 10, 1984)
  • K832287 — NOVA BALLOON THERMODILUTION INFUSION (October 19, 1983)
  • K822806 — BALLOON WEDGE PRESSURE, ANGIOGRAPHIC (November 1, 1982)
  • K812761 — FLOW-DIRECTED BALLOON THERMODILUTION (November 2, 1981)

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