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510(k) K951345

DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING by Catheter Research, Inc. — Product Code BZA

K951345 is an FDA 510(k) premarket notification submitted by Catheter Research, Inc. for the device "DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING". The FDA issued a decision of Substantially Equivalent on April 14, 1995. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Catheter Research, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1995
Date Received
March 23, 1995
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 Catheter Research, Inc.

  • K123258 — THE ADVANCE CATHETER FOR HSG AND SIS (January 31, 2013)
  • K120154 — INTRAUTERINE INSEMINATION (IUI) CATHETER (March 21, 2012)
  • K032835 — H/S CATHETER SET (December 11, 2003)
  • K020292 — UTERINE INJECTOR (April 17, 2002)
  • K973839 — DISPOSABLE ESOPHAGEAL STETHOSCOPE (March 19, 1998)
  • K974357 — UTERINE MANIPULATOR/INJECTOR (February 2, 1998)
  • K946044 — DISPOSABLE GAS SAMPLING LINES (December 27, 1994)

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)
  • 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)
  • K941026 — THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR (August 18, 1994)

FDA data resources