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510(k) K000004

ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 by Daig Corp. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2000
Date Received
January 3, 2000
Clearance Type
Traditional
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

Other clearances by Daig Corp.

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  • K982299 — SPYGLASS 5 FR ANGIOGRAPHIC CATHETER (October 19, 1998)
  • K982187 — FAST-CATH INTRA-CARDIAC INTRODUCER (September 16, 1998)
  • 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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