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510(k) K905458

SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER by Baxter Healthcare Corp — Product Code DQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1991
Date Received
December 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Oximeter, Fiber-Optic
Device Class
Class II
Regulation Number
870.1230
Review Panel
CV
Submission Type

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  • K061450 — HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE C (August 4, 2006)
  • K061159 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN (June 26, 2006)
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