Home / 510(k) Clearances / K920327

510(k) K920327

DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER by Daig Corp. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1992
Date Received
January 17, 1992
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)
  • K954317 — DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOP (November 28, 1995)
  • K944284 — CONTROL (March 3, 1995)

Other clearances for product code DYB

  • K260163 — AuST CSP Introducer (February 19, 2026)
  • K254236 — Peel-Away Introducer Sheath (February 9, 2026)
  • K253652 — Genie MAX Large Bore Introducer Sheath (January 22, 2026)
  • K252508 — Intri26 Introducer Sheath (December 17, 2025)
  • K253741 — V•Stick™ Vascular Access Set (December 15, 2025)
  • K252309 — PerQseal Introducers (October 23, 2025)
  • K251838 — Introducer Sheath Set (October 21, 2025)
  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K252441 — Primero Safe Access System (September 29, 2025)
  • K252227 — Pounce(TM) Sheath (September 24, 2025)