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510(k) K954317

DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS by Daig Corp. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1995
Date Received
September 15, 1995
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.

  • K000004 — ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 (November 29, 2000)
  • K994334 — ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX (May 15, 2000)
  • 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)
  • K944284 — CONTROL (March 3, 1995)
  • K942379 — DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER (December 27, 1994)

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