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510(k) K942392

AIRWAY CONNECTOR WITH FLEX TUBE by Mallinckrodt Medical — Product Code BZA

K942392 is an FDA 510(k) premarket notification submitted by Mallinckrodt Medical for the device "AIRWAY CONNECTOR WITH FLEX TUBE". The FDA issued a decision of Substantially Equivalent on August 22, 1994. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Mallinckrodt Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1994
Date Received
May 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Airway (Extension)
Device Class
Class I
Regulation Number
868.5810
Review Panel
AN
Submission Type

Other clearances by Mallinckrodt Medical

  • K082520 — SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES (October 2, 2008)
  • K051416 — SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA (June 16, 2005)
  • K972258 — HI-CARE CLOSED SUCTION SYSTEM (December 29, 1997)
  • K971267 — SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EX (September 25, 1997)
  • K963732 — PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF A (June 26, 1997)
  • K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA) (March 28, 1997)
  • K965132 — HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES (March 20, 1997)
  • K962045 — ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT (November 26, 1996)
  • K962173 — SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES (October 4, 1996)
  • K955680 — SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED (March 13, 1996)

Other clearances for product code BZA

  • K083702 — TRACH-ASSIST (March 5, 2009)
  • K954383 — SURELOC CIRCUIT CONNECTOR (December 22, 1995)
  • K954197 — DISPOSABLE FLEX TUBE (October 26, 1995)
  • K953786 — UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS (September 19, 1995)
  • K952824 — NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR (July 20, 1995)
  • K951345 — DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (April 14, 1995)
  • K944532 — PRIMA, INC. VENTILATOR HOSES (December 2, 1994)
  • K944535 — PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS (November 29, 1994)
  • K944534 — PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS (November 29, 1994)
  • K941026 — THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR (August 18, 1994)

FDA data resources