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510(k) K001063

SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 by Baxter Healthcare Corp — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2000
Date Received
April 3, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Flow Directed
Device Class
Class II
Regulation Number
870.1240
Review Panel
CV
Submission Type

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