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510(k) K853625

NOVA ARTERIAL EMBOLECTOMY CATHETER by Nova Medical Specialties — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1986
Date Received
August 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

Other clearances by Nova Medical Specialties

  • K872770 — DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. (October 15, 1987)
  • K860526 — NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH (May 2, 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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