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

• • Terminated Z-0937-2013 FDA Class II ·initiated 17 Dec 2012

  Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.

• • Terminated Z-0898-2013 FDA Class II ·initiated 13 Dec 2012

  The affected product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.

510(k) Number

K081904 ↗

FDA Product Code

LJS

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Raulerson One-Step Guidewire Insertion Bulb Needle

  Class II

  FDA 510(k) K971281 Active Cleared 9 Oct 1997

• 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

• Power Injectable Implantable Infusion Port With Silicone Lumen (Attachable and Pre-Attached)

  Class II

  FDA 510(k) K070003 Active Cleared 15 May 2007

See all devices from Medcomp →