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FDA 510(k)

LV-1 HEMOSTASIS VALVE, MODEL #6789

K-Number: K021282 · 2002-05-02

ApplicantGuidant Corp.
Decision Date2002-05-02
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LV-1 HEMOSTASIS VALVE, MODEL #6789 is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corp.. It received FDA 510(k) clearance on 2002-05-02 under 510(k) number K021282. 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 LV-1 HEMOSTASIS VALVE, MODEL #6789?

LV-1 HEMOSTASIS VALVE, MODEL #6789 is a medical device that received FDA 510(k) clearance on 2002-05-02. The listed applicant is Guidant Corp.. The 510(k) number is K021282.

When did LV-1 HEMOSTASIS VALVE, MODEL #6789 receive FDA 510(k) clearance?

LV-1 HEMOSTASIS VALVE, MODEL #6789 received FDA 510(k) clearance on 2002-05-02, under 510(k) number K021282.

Who is the listed applicant for LV-1 HEMOSTASIS VALVE, MODEL #6789?

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

What is the FDA product code for LV-1 HEMOSTASIS VALVE, MODEL #6789?

The FDA product code for LV-1 HEMOSTASIS VALVE, MODEL #6789 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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