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510(k) K813317

DISP. HYPERINFLATION BAG SYSTEM by Intec Medical, Inc. — Product Code NHK

K813317 is an FDA 510(k) premarket notification submitted by Intec Medical, Inc. for the device "DISP. HYPERINFLATION BAG SYSTEM". The FDA issued a decision of Substantially Equivalent on March 12, 1982. The device falls under product code NHK (Resuscitator, Manual, Non Self-Inflating), a Class II device regulated under 21 CFR 868.5905. Intec Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1982
Date Received
November 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resuscitator, Manual, Non Self-Inflating
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.

Other clearances by Intec Medical, Inc.

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

Other clearances for product code NHK

  • K092687 — VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER (November 23, 2009)
  • K020281 — MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM (February 11, 2002)
  • K013308 — VENTLAB HYPERINFLATION BAG SYSTEM (December 20, 2001)
  • K001714 — MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 (November 3, 2000)
  • K970785 — SIMS HYPERINFLATION BAG SYSTEM (June 13, 1997)
  • K952214 — SIMS INTERTECH HYPERINFLATION BAG SYSTEM (June 8, 1995)
  • K942571 — HYPER-INFLATION BAG (June 10, 1994)
  • K940255 — HYPERINFLATION BAG SYSTEM (February 17, 1994)
  • K894612 — INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM (September 8, 1989)

FDA data resources