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510(k) K994334

ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX by Daig Corp. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2000
Date Received
December 23, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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  • K973840 — FAST-CATH (TM) INTRA-CARDIAC INTRODUCER (May 21, 1998)
  • K964518 — FAST-CATH TRANSSEPTAL CATHETER INTRODUCER (May 14, 1997)
  • K965249 — SPYGLASS ANGIOGRAPHIC CATHETER (February 21, 1997)
  • K962805 — SPYGLASS ANGIOGRAPHIC CATHETER (October 15, 1996)
  • K954317 — DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOP (November 28, 1995)
  • K944284 — CONTROL (March 3, 1995)
  • K942379 — DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER (December 27, 1994)

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