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FDA 510(k)

GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER

K-Number: K052381 · 2005-11-21

ApplicantZerusa Limited
Decision Date2005-11-21
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Zerusa Limited. It received FDA 510(k) clearance on 2005-11-21 under 510(k) number K052381. 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 HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER?

GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER is a medical device that received FDA 510(k) clearance on 2005-11-21. The listed applicant is Zerusa Limited. The 510(k) number is K052381.

When did GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER receive FDA 510(k) clearance?

GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER received FDA 510(k) clearance on 2005-11-21, under 510(k) number K052381.

Who is the listed applicant for GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER?

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 HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER?

The FDA product code for GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER is DTL.

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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 VALVEK092711GUARDIAN II HEMOSTASIS VALVEK073620GUARDIAN HEMOSTASIS VALVE

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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