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Cardica C-Port X-Change Anastomosis System and Handle and Xa X-Change Subassemblies

by Cardica, Inc.

510(k) K073304

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK073304 Date20 Dec 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FZP
Device Class
Class II
Regulation
21 CFR Part 878.4300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cardica C-Port X-Change Anastomosis System is a device intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures. It is a second-generation device with improved toe clip design to enhance hemostasis at the toe.

The device is supplied as subassemblies and is classified as a Class II medical device with product code FZP. It is authorized under FDA 510(k) clearance with K number K073304, received on November 23, 2007, and decided on December 20, 2007. The device is intended for use in general and plastic surgery procedures.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Cardica C-Port X-Change Anastomosis System used for?

    The Cardica C-Port X-Change Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures. It is designed for use in both general and plastic surgery procedures.

  • How is the Cardica C-Port X-Change Anastomosis System supplied?

    The device is supplied as subassemblies and is classified as a Class II medical device with product code FZP. It includes the handle and XA X-Change subassemblies for complete functionality during surgical procedures.

  • What is the regulatory status of the Cardica C-Port X-Change Anastomosis System?

    The device is authorized under FDA 510(k) clearance with K number K073304, received on November 23, 2007, and decided on December 20, 2007. It is classified as a Class II medical device and is intended for use in general and plastic surgery procedures.

  • What distinguishes the second-generation Cardica C-Port X-Change Anastomosis System?

    The second-generation device features an improved toe clip design specifically engineered to enhance hemostasis at the toe, providing better performance during anastomosis procedures compared to previous versions.