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510(k) K982299

SPYGLASS 5 FR ANGIOGRAPHIC CATHETER by Daig Corp. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1998
Date Received
July 1, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

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  • K944284 — CONTROL (March 3, 1995)
  • K942379 — DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER (December 27, 1994)

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