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510(k) K940793

DOUBLE TRACH SWIVEL CONNECTOR by Seven Harvest Intl. Import & Export — Product Code BZA

K940793 is an FDA 510(k) premarket notification submitted by Seven Harvest Intl. Import & Export for the device "DOUBLE TRACH SWIVEL CONNECTOR". The FDA issued a decision of Substantially Equivalent on July 1, 1994. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Seven Harvest Intl. Import & Export has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1994
Date Received
February 22, 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 Seven Harvest Intl. Import & Export

  • K823506 — NASAL CANNULA (December 9, 1982)
  • K823141 — OXYGEN MASKS (November 29, 1982)
  • K823142 — OXYGEN TUBINGS (November 29, 1982)
  • K823143 — BUBBLE HUMIDIFIERS (November 29, 1982)
  • K820709 — AIRWAYS (June 25, 1982)
  • K813074 — CONNECTORS & ADAPTERS (December 31, 1981)

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)
  • K942392 — AIRWAY CONNECTOR WITH FLEX TUBE (August 22, 1994)

FDA data resources