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510(k) K162389

Medcomp Vessel Dilator by Medcomp ( Medical Components) — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2017
Date Received
August 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
Submission Type

Other clearances by Medcomp ( Medical Components)

  • K153238 — Dignity Dual Port (March 15, 2016)
  • K143238 — C3 Wave (April 24, 2015)
  • K132177 — MEDCOMP GEN III POWER INJECTABLE PORT (December 12, 2013)
  • K130897 — MEDCOMP VASCU-PICC WITH VALVE (October 22, 2013)
  • K110424 — DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROF (November 30, 2011)
  • K093309 — PRO-LINE CT (BASIC TRAY) MODEL MR28036101 (November 24, 2009)

Other clearances for product code DRE

  • K253616 — ProtekDilate Vascular Access Kit (December 19, 2025)
  • K251325 — VersaCross Connect™ Transseptal Dilator (May 29, 2025)
  • K242229 — Micro Ace Gold Advanced Micro Access System (January 15, 2025)
  • K241720 — VersaCross Connect™ Transseptal Dilator (July 12, 2024)
  • K233647 — VersaCross Connect™ Transseptal Dilator (December 14, 2023)
  • K232609 — Micro Ace™ Advanced Micro Access System (September 27, 2023)
  • K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guard (December 15, 2022)
  • K212784 — TightRail Guardian Motorized Dilator Sheath (August 24, 2022)
  • K211679 — Xtractor device (February 17, 2022)
  • K210734 — Endovascular Dilator and Sets (April 6, 2021)