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510(k) K942570

MAPLESON D CIRCUIT by Med-Plastics Intl., Inc. — Product Code CAI

K942570 is an FDA 510(k) premarket notification submitted by Med-Plastics Intl., Inc. for the device "MAPLESON D CIRCUIT". The FDA issued a decision of Substantially Equivalent on June 10, 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. Med-Plastics Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1994
Date Received
May 31, 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 Med-Plastics Intl., Inc.

  • K946209 — DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME (June 8, 1995)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)
  • K942568 — ADULT ANESTHESIA BREATHING CIRCUIT (June 10, 1994)
  • K942569 — VENTILATOR HOSE (June 10, 1994)
  • K942571 — HYPER-INFLATION BAG (June 10, 1994)
  • K942567 — MASS SPECTROMETRY MONITORING LINES AND CONNECTORS (June 10, 1994)
  • K932577 — PEDIATRIC GAS SAMPLING (July 22, 1993)
  • K932575 — ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (July 22, 1993)
  • K932576 — PEDIATRIC TEMPERATURE MONITORING CIRCUITS (July 22, 1993)
  • K932578 — ADULT GAS SAMPLING CIRCUITS (July 22, 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)
  • K952017 — PRIMA MAPLESON D CIRCUIT (May 22, 1995)
  • K952019 — PRIMA ADULT GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952018 — PRIMA COAXIAL CIRCUITS (May 22, 1995)
  • K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (May 22, 1995)
  • K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS (May 22, 1995)
  • K952009 — PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (May 19, 1995)

FDA data resources