Doppler Needle and Flow Monitor

• • Terminated Z-0132-2011 FDA Unclassified (pre-2012) ·initiated 5 May 2010

  The packaging of the vascular access device may potentially become damaged, compromising the sterility of the product. Use of a non-sterile product increases risk of patient infection. This recall involes: Model 78050 18 Gauge PD Access Vascular Access Device, Model 78060 Extended 18 Gauge PD Access Vascular Access Device, Model 75010 18 Gauge SmartNeedle Vascular Access Devices with Expiration Da

510(k) Number

K903625 ↗

FDA Product Code

DPW

Device Class

Class II

Regulation

21 CFR Part 870.2100

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Balloon Dilatation Catheter

  Class II

  FDA 510(k) K894944 Active Cleared 19 Jan 1990

• Smartneedle(Tm) Vascular Access System

  Class II

  FDA 510(k) K913746 Active Cleared 17 Dec 1991

• PSG EDM Infusion Catheter

  Class II

  FDA 510(k) K895932 Active Cleared 4 Jan 1990

• Guiding Catheter

  Class II

  FDA 510(k) K895146 Active Cleared 19 Jan 1990

• Smartneedle(R) Over-the-Needle Catheter

  Class II

  FDA 510(k) K932777 Active Cleared 7 Oct 1993

• Vantage Dialtaion Catheter

  Class II

  FDA 510(k) K934433 Active Cleared 9 Dec 1993

See all devices from Peripheral Systems Group →