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510(k) K100518

INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 by Instrumed International, Inc. — Product Code DWP

K100518 is an FDA 510(k) premarket notification submitted by Instrumed International, Inc. for the device "INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054". The FDA issued a decision of Substantially Equivalent on August 31, 2010. The device falls under product code DWP (Dilator, Vessel, Surgical), a Class II device regulated under 21 CFR 870.4475. Instrumed International, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2010
Date Received
February 23, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, Surgical
Device Class
Class II
Regulation Number
870.4475
Review Panel
CV
Submission Type

Other clearances by Instrumed International, Inc.

  • K100517 — INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX (April 29, 2010)
  • K092840 — INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (December 3, 2009)
  • K092544 — INSTRUMED VASCULAR CLAMPS (October 26, 2009)
  • K081651 — INSTRUMED RONGEUR (August 8, 2008)
  • K071771 — INSTRUMED RETRACTORS (August 2, 2007)
  • K040855 — INSTRUMED LAPAROSCOPE AND ACCESSORIES (April 16, 2004)

Other clearances for product code DWP

  • K220981 — SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (April 20, 2023)
  • K183438 — Geomed Vascular Dilators (September 3, 2019)
  • K163524 — Vessel Dilator (June 29, 2017)
  • K130896 — VASCULAR PROBE, VASCULAR PROBE ES (April 24, 2013)
  • K030788 — KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS (July 12, 2003)
  • K960312 — RDI CARDIAC INSULATION PAD (April 19, 1996)
  • K912548 — LEMAITRE-BOOKWALTER VESSEL DEVICES (September 18, 1991)
  • K911475 — LAPAROSCOPIC VESSEL ARTICULATOR (July 2, 1991)
  • K910682 — ROBICSEK PROBE/RETRACTOR (May 8, 1991)
  • K905159 — FLO-RESTER(R) VESSEL SIZER (February 7, 1991)

FDA data resources