Home / 510(k) Clearances / K082644

510(k) K082644

GLIDESHEATH by Terumo Medical Corp. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2008
Date Received
September 11, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Terumo Medical Corp.

  • K111606 — PINNACLE PRECISION ACCESS SYSTEM (October 3, 2011)
  • K111556 — GLIDECROSS SUPPORT CATHETER (July 29, 2011)
  • K110540 — TERUMO SUPPORT CATHETER (May 13, 2011)
  • K102008 — GLIDESHEATH (July 21, 2010)
  • K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (May 29, 2009)
  • K082997 — TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER (April 15, 2009)
  • K090040 — RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) (February 6, 2009)
  • K082847 — PINNACLE ROII INTRODUCER SHEATH (October 29, 2008)
  • K082519 — FINECROSS MG CORONARY MICRO-GUIDE CATHETER (September 26, 2008)
  • K082736 — RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER (September 24, 2008)

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)