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510(k) K872770

DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. by Nova Medical Specialties — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1987
Date Received
July 14, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Flow Directed
Device Class
Class II
Regulation Number
870.1240
Review Panel
CV
Submission Type

Other clearances by Nova Medical Specialties

  • K860526 — NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH (May 2, 1986)
  • 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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