Home / 510(k) Clearances / K911184

510(k) K911184

SCANLAN/TAHERI VALVULOTOME by Scanlan Intl., Inc. — Product Code MGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1992
Date Received
March 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valvulotome
Device Class
Class II
Regulation Number
870.4885
Review Panel
CV
Submission Type

Other clearances by Scanlan Intl., Inc.

  • K960372 — SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM (April 26, 1996)
  • K945474 — SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER (December 5, 1994)
  • K864919 — SCANLAN (TM) VEIN/GRAFT HOLDER (January 12, 1987)
  • K864920 — SCANLAN (TM) INSTRUMENT TRAY (January 12, 1987)
  • K851825 — SCANLAN TUNNELER, SHEATH & TIP (July 12, 1985)
  • K841521 — SCANLAN ENDARSECTOR (August 3, 1984)
  • K841513 — SCANLAN ATRAUM INSTRUMENT JAW COVER (July 6, 1984)
  • K841085 — SCANLAN COLORMARK SKIN MARKER (June 11, 1984)
  • K841514 — SCANLAN VASCU-STATT II APPROXIMATOR (June 5, 1984)
  • K841515 — SCANLAN VASCU-STATT II (June 5, 1984)

Other clearances for product code MGZ

  • K250105 — Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) (July 3, 2025)
  • K221902 — LimFlow Vector (December 21, 2022)
  • K190267 — EZE SIT Valvulotome (October 30, 2019)
  • K142660 — Antegrade LeMills Valvulotome (October 17, 2014)
  • K140042 — 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME (April 10, 2014)
  • K132047 — LEMILLS VALVULOTOME (November 5, 2013)
  • K132190 — EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME (August 5, 2013)
  • K111884 — OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME (July 29, 2011)
  • K080178 — VALVULOTOME BY KOVEN (July 28, 2008)
  • K022823 — VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 (July 1, 2004)