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FDA 510(k)

D-STAT HANDLE, MODEL 8500-053

K-Number: K063871 · 2007-02-28

ApplicantVascular Solutions, Inc.
Decision Date2007-02-28
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

D-STAT HANDLE, MODEL 8500-053 is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2007-02-28 under 510(k) number K063871. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D-STAT HANDLE, MODEL 8500-053?

D-STAT HANDLE, MODEL 8500-053 is a medical device that received FDA 510(k) clearance on 2007-02-28. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K063871.

When did D-STAT HANDLE, MODEL 8500-053 receive FDA 510(k) clearance?

D-STAT HANDLE, MODEL 8500-053 received FDA 510(k) clearance on 2007-02-28, under 510(k) number K063871.

Who is the listed applicant for D-STAT HANDLE, MODEL 8500-053?

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

What is the FDA product code for D-STAT HANDLE, MODEL 8500-053?

The FDA product code for D-STAT HANDLE, MODEL 8500-053 is DXC.

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Related Devices (Code: DXC)

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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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