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510(k) K954480

CONDENSATE COLLECTION KIT by Nova-Ventrx — Product Code CAI

K954480 is an FDA 510(k) premarket notification submitted by Nova-Ventrx for the device "CONDENSATE COLLECTION KIT". The FDA issued a decision of Substantially Equivalent on December 29, 1995. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Nova-Ventrx has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1995
Date Received
September 26, 1995
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 Nova-Ventrx

  • K952267 — CRITERION, CRITERION I.V., MODIFIED (December 2, 1997)
  • K893760 — CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 (August 10, 1989)
  • K881207 — RES-Q 1, 2, 3, 4 AND 5 (August 15, 1988)
  • K870382 — DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011 (March 6, 1987)
  • K863756 — MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT (November 13, 1986)
  • K850600 — CO-AX VENTILATOR CIRCUIT (May 2, 1985)
  • K842794 — MAXI-MISER HUMIDIFIER INSERT 1020 & 1021 (October 4, 1984)
  • K842795 — MAXI-MISER HUMIDIFIER INSERT 1030 (October 4, 1984)
  • K841569 — MAXI-MISER HUMIDIFIER INSERT 1020 (May 30, 1984)
  • K841571 — MAXI-MISER WATER TRANSFER SET 1021/1022 (May 30, 1984)

Other clearances for product code CAI

  • K953787 — UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT (September 19, 1995)
  • K953788 — UNICOR, INC. GAS SAMPLING LINES & CONNECTORS (September 19, 1995)
  • K952017 — PRIMA MAPLESON D CIRCUIT (May 22, 1995)
  • K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS (May 22, 1995)
  • K952019 — PRIMA ADULT GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952018 — PRIMA COAXIAL CIRCUITS (May 22, 1995)
  • K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (May 22, 1995)
  • K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952009 — PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (May 19, 1995)
  • K945565 — SPIRO-FLEX (January 13, 1995)

FDA data resources