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510(k) K834037

HEPARIN COATED BALLOON THERMODILU by Nova Medical Specialties — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1984
Date Received
November 23, 1983
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

  • K872770 — DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. (October 15, 1987)
  • 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)
  • 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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  • K160084 — Swan Ganz Catheters (May 3, 2016)
  • K094048 — PERCUPRO MESSENGER BALLOON CATHETER (July 14, 2011)
  • K081052 — OCCLUSION BALLOON CATHETER, MODEL VENOS (June 18, 2008)
  • K010253 — ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ (March 19, 2002)