Home / 510(k) Clearances / K944107

510(k) K944107

VIP PLUS PERCUTANEOUS INTRODUCER by Medamicus, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1994
Date Received
August 23, 1994
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 Medamicus, Inc.

  • K040150 — MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER (February 18, 2004)
  • K030905 — MEDAMICUS FLOWGUARD PEELABLE INTRODUCER (April 9, 2003)
  • K022689 — MODIFICATION TO MEDAMICUS AXIA RSN (August 23, 2002)
  • K021004 — VALVED PEELABLE INTRODUCER (June 6, 2002)
  • K020563 — MEDAMICUS AXIA RSN (May 21, 2002)
  • K013120 — PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 (January 24, 2002)
  • K011085 — GUIDEWIRE INTRODUCER SAFETY NEEDLE (July 9, 2001)
  • K000824 — PERCUTANEOUS INTRODUCER, MODEL 10383-XXX (April 13, 2000)
  • K994097 — MEDAMICUS EPIDURAL INTRODUCER (March 1, 2000)
  • K990705 — MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR S (June 28, 1999)

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)