Medcomp Vessel Dilator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K162389 ↗

FDA Product Code

DRE

Device Class

Class II

Regulation

21 CFR Part 870.1310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Medcomp Gen III Power Injectable Port Open recall

  Class II

  FDA 510(k) K132177 Active Cleared 12 Dec 2013

• ArchFlo CT Midline

  Class II

  FDA 510(k) K171483 Active Cleared 15 Dec 2017

• Medcomp Vascu-Picc with Valve

  Class II

  FDA 510(k) K130897 Active Cleared 22 Oct 2013

• C3 Wave

  Class II

  FDA 510(k) K143238 Active Cleared 24 Apr 2015

• 20G x 5/8 Pro-Lock CT Safety Infusion Set

  Class II

  FDA 510(k) K171333 Active Cleared 18 Jul 2017

• Dignity Dual Port

  Class II

  FDA 510(k) K153238 Active Cleared 15 Mar 2016

See all devices from Medcomp (Medical Components, Inc.) →