Trellis Plus Infusion System (140cm Catheter Length 10cm Infusion Length 20cm (100cm Catheter Length 10cm Infusion H

• • Terminated Z-0816-04 FDA Unclassified (pre-2012) ·initiated 24 Nov 2003 ·on shared 510(k) K021958

  The device has the potential for fractures at the distal end during use.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K021958 ↗

FDA Product Code

QEY

Device Class

Class II

Regulation

21 CFR Part 870.5150

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Trellis Infusion System (10cm Infusion Length); Trellis Infusion System (20cm Infusion Length)

  Class II

  FDA 510(k) K013635 Active Cleared 11 Feb 2002

• TRELLIS-6 Peripheral Infusion System (140CM Catheter Length, 10CM Infusion Length)

  Class II

  FDA 510(k) K023514 Active Cleared 2 Dec 2002

• Bacchus Thrombectomy Catheter (Btc), Model Btc-0755

  Class II

  FDA 510(k) K003570 Active Cleared 6 Jun 2001

• Trellis Reserve Infusion System

  Class II

  FDA 510(k) K032261 Active Cleared 22 Aug 2003

• Solera Magnum Thrombectomy Catheter, 55 Cm, Model Bac Smg 007 055 & Solera Magnum Thrombectomy Catheter, 110 Cm

  Class II

  FDA 510(k) K022640 Active Cleared 2 Dec 2002

• Trellis-6 Peripheral Infusion System

  Class II

  FDA 510(k) K071664 Active Cleared 13 Jul 2007

See all devices from Bacchus Vascular, Inc. →