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FDA 510(k)

C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM

K-Number: K070548 · 2007-03-29

ApplicantCardica, Inc.
Decision Date2007-03-29
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

C-PORT FLEXA 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 2007-03-29 under 510(k) number K070548. 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 FLEXA DISTAL ANASTOMOSIS SYSTEM?

C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-29. The listed applicant is Cardica, Inc.. The 510(k) number is K070548.

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

C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM received FDA 510(k) clearance on 2007-03-29, under 510(k) number K070548.

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

The FDA product code for C-PORT FLEXA 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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