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FDA 510(k)

CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE

K-Number: K082930 · 2009-02-13

ApplicantCardiva Medical, Inc.
Decision Date2009-02-13
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE is the device name listed in this FDA 510(k) record. The listed applicant is Cardiva Medical, Inc.. It received FDA 510(k) clearance on 2009-02-13 under 510(k) number K082930. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE?

CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE is a medical device that received FDA 510(k) clearance on 2009-02-13. The listed applicant is Cardiva Medical, Inc.. The 510(k) number is K082930.

When did CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE receive FDA 510(k) clearance?

CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE received FDA 510(k) clearance on 2009-02-13, under 510(k) number K082930.

Who is the listed applicant for CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE?

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

What is the FDA product code for CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE?

The FDA product code for CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE is DXC.

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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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