Home / 510(k) Clearances / K073100

510(k) K073100

INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S by Oscor, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2007
Date Received
November 2, 2007
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

Other clearances by Oscor, Inc.

  • K210627 — Breezeway II (June 3, 2021)
  • K151951 — Destino Reach (September 22, 2015)
  • K143463 — IS4/DF4 Port Plug (March 19, 2015)
  • K140917 — INTRODUCER, MODEL ADELANTE MAGNUM (July 9, 2014)
  • K140406 — DESTINO TWIST, STEERABLE GUIDING SHEATH (April 17, 2014)
  • K130633 — INTRODUCER SETS, MODEL ADELANTE RADIAL (February 13, 2014)
  • K130843 — SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE (January 8, 2014)
  • K130104 — GUIDEWIRE, PURSUER SERIES (June 13, 2013)
  • K122960 — STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO (December 13, 2012)
  • K122958 — DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY (December 13, 2012)

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)