Guidant Proximal Seal System, Models PSS-4500 & PS-4500

• • Terminated Z-0940-2011 FDA Unclassified (pre-2012) ·initiated 5 May 2010

  Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate.

510(k) Number

K022880 ↗

FDA Product Code

DXC

Device Class

Class II

Regulation

21 CFR Part 870.4450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Guidant Corp. →

• What is the primary purpose of the Guidant Proximal Seal System?

  This device is designed to establish a hemostatic environment at the proximal anastomosis site during coronary artery bypass graft surgery. It allows surgeons to complete the anastomosis without needing to use a side-biter or cross-clamp on the aorta, which helps reduce the amount of aortic manipulation required during the procedure.

• In which surgical settings can this device be used?

  The system is intended for use by cardiac surgeons in the operating room. It is suitable for both on-pump and off-pump cardiac surgery procedures, providing flexibility for different surgical approaches.

• What are the available model numbers for this system?

  The Guidant Proximal Seal System is available in two specific models: PSS-4500 and PS-4500. Both models are designed to meet the requirements for proximal anastomosis procedures as outlined in the device specifications.

• What is the regulatory status of this device?

  The Guidant Proximal Seal System has received FDA 510(k) clearance. This indicates that the device has been reviewed through a traditional submission process and was found to be substantially equivalent to other legally marketed devices.