Home / 510(k) Clearances / K142183

510(k) K142183

GLIDESHEATH SLENDER by Terumo Medical Corporation — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2014
Date Received
August 8, 2014
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 Terumo Medical Corporation

  • K231044 — R2P Navicross (July 27, 2023)
  • K213531 — TR BAND Radial Compression Device (December 20, 2021)
  • K193125 — R2P Destination Slender Guiding Sheath (January 6, 2020)
  • K181237 — Glidesheath Slender Tibial Pedal Kit (August 3, 2018)
  • K173831 — Glidesheath Slender (May 8, 2018)
  • K172995 — Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Desti (November 21, 2017)
  • K171491 — R2P Destination Slender Guiding Sheath (October 5, 2017)
  • K152173 — Glidesheath (December 1, 2015)
  • K152525 — TR BAND Radial Compression Device (November 10, 2015)
  • K151471 — Radifocus Glidewire Endoscopic Wire (September 17, 2015)

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)