Home / 510(k) Clearances / K903463

510(k) K903463

IVT INTRODUCER SHEATH by Intensive Technology, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1991
Date Received
August 1, 1990
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 Intensive Technology, Inc.

  • K922970 — INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM (January 13, 1993)
  • K912664 — TEC ROTATING DUAL HEMOVALVE (August 24, 1992)
  • K911869 — IVT GUIDING CATHETER (October 16, 1991)
  • K904003 — HEMOCHRON(R) HEPARIN RESPONSE TEST (November 29, 1990)
  • K901767 — MODIFIED IVT PERIPHERAL ATHERECTOMY (June 28, 1990)
  • K896403 — MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM (March 6, 1990)
  • K895903 — IVT 0.014 GUIDE WIRE (January 4, 1990)
  • K892209 — APTT BY HEMOCHRON(R) (June 22, 1989)
  • K890515 — PERIPHERAL ATHERECTOMY SYSTEM (May 23, 1989)
  • K882804 — 0.014 PERIPHERAL GUIDE WIRE (October 28, 1988)

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)