FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

THORATEC GAS SAMPLING CONNECTOR

K Number: K822769 · Decision Oct 6, 1982
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
10
Review Days
22

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Basic Information

Device Name
THORATEC GAS SAMPLING CONNECTOR
K Number
K822769
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5240
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Thoratec Laboratories Corp.
Date Received
September 14, 1982
Decision Date
October 6, 1982
Product Code
CAI
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

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K001926 VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES
K851495 THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY
K833714 RESPIRATORY ASSESSMENT SYSTEM
K833265 RESPIRATORY FLOW MODULE
K831557 INTRAOPERATIVE AUTOTRANSFUSION SYS
K823449 RESPIRATORY GAS ANALYZER
K823287 RESPIRATORY CIRCUIT ADAPTOR
K780247 IMPCO DISPOSABLE AORTIC PUNCH