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FDA 510(k)

C-PORT DISTAL ANASTOMOSIS SYSTEM

K-Number: K053524 · 2006-11-16

ApplicantCardica, Inc.
Decision Date2006-11-16
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

C-PORT DISTAL ANASTOMOSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardica, Inc.. It received FDA 510(k) clearance on 2006-11-16 under 510(k) number K053524. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-PORT DISTAL ANASTOMOSIS SYSTEM?

C-PORT DISTAL ANASTOMOSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2006-11-16. The listed applicant is Cardica, Inc.. The 510(k) number is K053524.

When did C-PORT DISTAL ANASTOMOSIS SYSTEM receive FDA 510(k) clearance?

C-PORT DISTAL ANASTOMOSIS SYSTEM received FDA 510(k) clearance on 2006-11-16, under 510(k) number K053524.

Who is the listed applicant for C-PORT DISTAL ANASTOMOSIS SYSTEM?

The FDA 510(k) record lists Cardica, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-PORT DISTAL ANASTOMOSIS SYSTEM?

The FDA product code for C-PORT DISTAL ANASTOMOSIS SYSTEM is FZP.

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Related Devices (Code: FZP)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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