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FDA 510(k)

VasoStat Hemostasis Device

K-Number: K153259 · 2016-01-06

ApplicantForge Medical, Inc.
Decision Date2016-01-06
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VasoStat Hemostasis Device is the device name listed in this FDA 510(k) record. The listed applicant is Forge Medical, Inc.. It received FDA 510(k) clearance on 2016-01-06 under 510(k) number K153259. 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 VasoStat Hemostasis Device?

VasoStat Hemostasis Device is a medical device that received FDA 510(k) clearance on 2016-01-06. The listed applicant is Forge Medical, Inc.. The 510(k) number is K153259.

When did VasoStat Hemostasis Device receive FDA 510(k) clearance?

VasoStat Hemostasis Device received FDA 510(k) clearance on 2016-01-06, under 510(k) number K153259.

Who is the listed applicant for VasoStat Hemostasis Device?

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

What is the FDA product code for VasoStat Hemostasis Device?

The FDA product code for VasoStat Hemostasis Device is DXC.

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

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

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