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510(k) K913940

RESPONSE(TM) STEERABLE CATHETER by Daig Corp. — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1993
Date Received
September 3, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Steerable
Device Class
Class II
Regulation Number
870.1280
Review Panel
CV
Submission Type

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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)

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