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FDA 510(k)

VASOSTASIS VASCULAR CLOSURE SYSTEM

K-Number: K041486 · 2004-10-22

ApplicantCardiva Medical, Inc.
Decision Date2004-10-22
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASOSTASIS VASCULAR CLOSURE 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 2004-10-22 under 510(k) number K041486. 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 VASOSTASIS VASCULAR CLOSURE SYSTEM?

VASOSTASIS VASCULAR CLOSURE SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-22. The listed applicant is Cardiva Medical, Inc.. The 510(k) number is K041486.

When did VASOSTASIS VASCULAR CLOSURE SYSTEM receive FDA 510(k) clearance?

VASOSTASIS VASCULAR CLOSURE SYSTEM received FDA 510(k) clearance on 2004-10-22, under 510(k) number K041486.

Who is the listed applicant for VASOSTASIS VASCULAR CLOSURE 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 VASOSTASIS VASCULAR CLOSURE SYSTEM?

The FDA product code for VASOSTASIS VASCULAR CLOSURE 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.

K130124CATALYST II AND IIIK082930CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATEK072297BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEMK070485BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58LK051817BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEMK061075BOOMERANG WIRE

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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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