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510(k) K860941

DISPOSABLE HEATED WIRE LOOPS 48 AND 72 by Intec Medical, Inc. — Product Code BZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1986
Date Received
March 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Device Class
Class II
Regulation Number
868.5270
Review Panel
AN
Submission Type

Other clearances by Intec Medical, Inc.

  • K911840 — INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER (June 3, 1991)
  • K903217 — TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER (October 19, 1990)
  • K900710 — INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER (October 19, 1990)
  • K903216 — THE GUIDER CORONARY GUIDING CATHETER (October 19, 1990)
  • K903840 — GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY (October 16, 1990)
  • 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)
  • K823271 — DISPOSABLE ADULT VO. VENTILATOR CIRCUIT (December 22, 1982)

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