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FDA 510(k)

GUARDIAN II HEMOSTASIS VALVE

K-Number: K092711 · 2009-10-01

ApplicantZerusa Limited
Decision Date2009-10-01
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUARDIAN II HEMOSTASIS VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Zerusa Limited. It received FDA 510(k) clearance on 2009-10-01 under 510(k) number K092711. 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 HEMOSTASIS VALVE is a medical device that received FDA 510(k) clearance on 2009-10-01. The listed applicant is Zerusa Limited. The 510(k) number is K092711.

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

GUARDIAN II HEMOSTASIS VALVE received FDA 510(k) clearance on 2009-10-01, under 510(k) number K092711.

Who is the listed applicant for GUARDIAN II HEMOSTASIS VALVE?

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

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

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

Related Clinical Trials

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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Other records listing Zerusa Limited 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.

K101113GUARDIAN II NC HEMOSTASIS VALVEK073620GUARDIAN HEMOSTASIS VALVEK052381GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER

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.

K131124COLIGNJilin Coronado Medical , Ltd.K123448AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVEMedtronic, Inc.K122811CONNECTOR COMPONENTS WITH BALANCE BIOSURFACEMedtronic, Inc.K122301GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVEVascular Solutions Zerusa , Ltd.K120069MEDLINE STOPCOCK AND MANIFOLDMedline Industries, Inc.K113148E-PASSSynexmed(Shenzhen)Company Limited

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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