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FDA 510(k)

GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE

K-Number: K122301 · 2012-09-07

ApplicantVascular Solutions Zerusa , Ltd.
Decision Date2012-09-07
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions Zerusa , Ltd.. It received FDA 510(k) clearance on 2012-09-07 under 510(k) number K122301. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE?

GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE is a medical device that received FDA 510(k) clearance on 2012-09-07. The listed applicant is Vascular Solutions Zerusa , Ltd.. The 510(k) number is K122301.

When did GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE receive FDA 510(k) clearance?

GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE received FDA 510(k) clearance on 2012-09-07, under 510(k) number K122301.

Who is the listed applicant for GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE?

The FDA 510(k) record lists Vascular Solutions Zerusa , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE?

The FDA product code for GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE is DTL.

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Related Devices (Code: DTL)

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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