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510(k) K900710

INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER by Intec Medical, Inc. — Product Code KRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1990
Date Received
February 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Thermodilution
Device Class
Class II
Regulation Number
870.1915
Review Panel
CV
Submission Type

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  • K903906 — PERCUTANEOUS CATHETER INTRODUCER KIT (September 26, 1990)
  • K900998 — INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE (August 14, 1990)
  • K901247 — TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES (July 31, 1990)
  • K894925 — AMCATH URETERAL DILATORS MODELS 7100,7110,7120 (December 13, 1989)
  • K860941 — DISPOSABLE HEATED WIRE LOOPS 48 AND 72 (April 2, 1986)
  • K823271 — DISPOSABLE ADULT VO. VENTILATOR CIRCUIT (December 22, 1982)

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  • K902627 — INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. (February 25, 1991)
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