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510(k) K945314

CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING by Cleveland Tubing, Inc. — Product Code CAI

K945314 is an FDA 510(k) premarket notification submitted by Cleveland Tubing, Inc. for the device "CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING". The FDA issued a decision of Substantially Equivalent on November 18, 1994. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Cleveland Tubing, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1994
Date Received
November 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device Class
Class I
Regulation Number
868.5240
Review Panel
AN
Submission Type

Other clearances by Cleveland Tubing, Inc.

  • K940889 — CONNECTORS AND AIRWAY EXTENSIONS (November 10, 1994)
  • K940890 — CORRUGATED TUBING (November 10, 1994)
  • K932119 — CLEVELAND TUBING, INC. VENTILATOR HOSES (June 23, 1993)

Other clearances for product code CAI

  • K954480 — CONDENSATE COLLECTION KIT (December 29, 1995)
  • K953788 — UNICOR, INC. GAS SAMPLING LINES & CONNECTORS (September 19, 1995)
  • K953787 — UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT (September 19, 1995)
  • K952018 — PRIMA COAXIAL CIRCUITS (May 22, 1995)
  • K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (May 22, 1995)
  • K952017 — PRIMA MAPLESON D CIRCUIT (May 22, 1995)
  • K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS (May 22, 1995)
  • K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952019 — PRIMA ADULT GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952009 — PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (May 19, 1995)

FDA data resources