Valved Tearway Introducer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K090394 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Raulerson One-Step Guidewire Insertion Bulb Needle

  Class II

  FDA 510(k) K971281 Active Cleared 9 Oct 1997

• Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)

  Class II

  FDA 510(k) K081904 Active Cleared 23 Sep 2008

• Medcomp Ash Split-Cath 28cm, Medcomp Ash Split-Cath 32cm

  Class II

  FDA 510(k) K972207 Active Cleared 23 Feb 1998

• Split Cath Rg

  Class II

  FDA 510(k) K130889 Active Cleared 28 Apr 2014

• Medcomp Split-Cath II

  Class II

  FDA 510(k) K040318 Active Cleared 3 Feb 2005

• Medcomp Split Cath II

  Class II

  FDA 510(k) K051280 Active Cleared 30 Nov 2005

See all devices from Medcomp →