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510(k) K822769

THORATEC GAS SAMPLING CONNECTOR by Thoratec Laboratories Corp. — Product Code CAI

K822769 is an FDA 510(k) premarket notification submitted by Thoratec Laboratories Corp. for the device "THORATEC GAS SAMPLING CONNECTOR". The FDA issued a decision of Substantially Equivalent on October 6, 1982. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Thoratec Laboratories Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1982
Date Received
September 14, 1982
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 Thoratec Laboratories Corp.

  • K001927 — VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASC (December 18, 2000)
  • K001926 — VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CU (September 22, 2000)
  • K851495 — THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY (August 1, 1985)
  • K833714 — RESPIRATORY ASSESSMENT SYSTEM (December 29, 1983)
  • K833265 — RESPIRATORY FLOW MODULE (November 28, 1983)
  • K831557 — INTRAOPERATIVE AUTOTRANSFUSION SYS (August 24, 1983)
  • K823449 — RESPIRATORY GAS ANALYZER (January 5, 1983)
  • K823287 — RESPIRATORY CIRCUIT ADAPTOR (December 9, 1982)
  • K780247 — IMPCO DISPOSABLE AORTIC PUNCH (February 27, 1978)

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)
  • K952017 — PRIMA MAPLESON D CIRCUIT (May 22, 1995)
  • K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS (May 22, 1995)
  • K952018 — PRIMA COAXIAL CIRCUITS (May 22, 1995)
  • K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952019 — PRIMA ADULT GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (May 22, 1995)
  • K952009 — PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (May 19, 1995)

FDA data resources