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510(k) K903840

GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY by Intec Medical, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1990
Date Received
August 21, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Intec Medical, Inc.

  • K911840 — INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER (June 3, 1991)
  • K900710 — INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER (October 19, 1990)
  • K903217 — TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER (October 19, 1990)
  • K903216 — THE GUIDER CORONARY GUIDING CATHETER (October 19, 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)
  • K860941 — DISPOSABLE HEATED WIRE LOOPS 48 AND 72 (April 2, 1986)
  • K823271 — DISPOSABLE ADULT VO. VENTILATOR CIRCUIT (December 22, 1982)

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