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510(k) K924627

XTEND CIRCUITS (TM) by Arc Medical, Inc. — Product Code CAI

K924627 is an FDA 510(k) premarket notification submitted by Arc Medical, Inc. for the device "XTEND CIRCUITS (TM)". The FDA issued a decision of Substantially Equivalent on April 7, 1993. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Arc Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1993
Date Received
September 14, 1992
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 Arc Medical, Inc.

  • K090738 — THERMOFLO HCH, THERMOFLO FILTER (July 27, 2009)
  • K063125 — FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) (April 13, 2007)
  • K011212 — FILTERFLO H (December 20, 2001)
  • K982239 — CIRCUIT GUARD (August 14, 1998)
  • K924997 — EDD (March 28, 1995)

Other clearances for product code CAI

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

FDA data resources