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

• • Terminated Z-0817-04 FDA Unclassified (pre-2012) ·initiated 24 Nov 2003 ·on shared 510(k) K023514

  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

K023514 ↗

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

• 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

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

  Class II

  FDA 510(k) K021958 Active Cleared 3 Jul 2002

• 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. →

• What is the primary purpose of the Trellis-6 Peripheral Infusion System in clinical procedures?

  The Trellis-6 Peripheral Infusion System is designed for peripheral vascular procedures to deliver targeted thrombolytic treatments. It uses two distal compliant balloons to isolate a treatment zone while allowing precise infusion of fluids through strategically placed holes between the balloons. An integrated Dispersion Wire, powered by an Oscillation Drive Unit, further enhances fluid dispersion within the isolated segment to improve therapeutic delivery efficiency.

• Is the Trellis-6 Peripheral Infusion System intended for single-use or reusable applications?

  The Trellis-6 Peripheral Infusion System is explicitly described as a reusable device, intended for use in controlled clinical settings like cardiovascular procedures. This classification aligns with its design for repeated use in procedural environments where sterility and maintenance protocols can be strictly managed.

• What are the key dimensions of the Trellis-6 catheter, and why do they matter?

  The Trellis-6 catheter features a total length of 140 cm with a 10 cm infusion segment. These dimensions are critical for procedural compatibility, ensuring the device can navigate and effectively treat target vascular regions during peripheral interventions. The infusion length determines the treatment zone size, while the total length ensures reachability to specific anatomical locations.

• How is the Trellis-6 Peripheral Infusion System regulated, and what does that mean for clinicians?

  The Trellis-6 Peripheral Infusion System has received FDA 510(k) clearance as substantially equivalent to a predicate device, classified under product code QEY and regulation number 870.5150. This means it has undergone regulatory review to confirm safety and effectiveness for its intended use in mechanical thrombolysis procedures, providing clinicians with assurance of compliance with U.S. medical device standards.

• Are there any specific storage or handling requirements mentioned for the Trellis-6 system?

  The provided data does not specify storage or handling requirements for the Trellis-6 system, such as sterility assurances or environmental conditions. Clinicians should refer to the manufacturer’s instructions for proper storage, preparation, and maintenance to ensure optimal performance and safety during use.