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FDA 510(k)

PASSAGE HEMOSTASIS VALVE

K-Number: K925419 · 1993-01-22

ApplicantMerit Medical Systems, Inc.
Decision Date1993-01-22
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PASSAGE HEMOSTASIS VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 1993-01-22 under 510(k) number K925419. 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 PASSAGE HEMOSTASIS VALVE?

PASSAGE HEMOSTASIS VALVE is a medical device that received FDA 510(k) clearance on 1993-01-22. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K925419.

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

PASSAGE HEMOSTASIS VALVE received FDA 510(k) clearance on 1993-01-22, under 510(k) number K925419.

Who is the listed applicant for PASSAGE HEMOSTASIS VALVE?

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

What is the FDA product code for PASSAGE HEMOSTASIS VALVE?

The FDA product code for PASSAGE 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

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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