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FDA 510(k)

BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM

K-Number: K072297 · 2007-09-12

ApplicantCardiva Medical, Inc.
Decision Date2007-09-12
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM 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 2007-09-12 under 510(k) number K072297. 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 BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM?

BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM is a medical device that received FDA 510(k) clearance on 2007-09-12. The listed applicant is Cardiva Medical, Inc.. The 510(k) number is K072297.

When did BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM receive FDA 510(k) clearance?

BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM received FDA 510(k) clearance on 2007-09-12, under 510(k) number K072297.

Who is the listed applicant for BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM?

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 BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM?

The FDA product code for BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM is DXC.

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Other records listing Cardiva Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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