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FDA 510(k)

VASCULAR SOLUTIONS SCLERO-KIT

K-Number: K043019 · 2004-12-01

ApplicantVascular Solutions, Inc.
Decision Date2004-12-01
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VASCULAR SOLUTIONS SCLERO-KIT 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 2004-12-01 under 510(k) number K043019. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCULAR SOLUTIONS SCLERO-KIT?

VASCULAR SOLUTIONS SCLERO-KIT is a medical device that received FDA 510(k) clearance on 2004-12-01. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K043019.

When did VASCULAR SOLUTIONS SCLERO-KIT receive FDA 510(k) clearance?

VASCULAR SOLUTIONS SCLERO-KIT received FDA 510(k) clearance on 2004-12-01, under 510(k) number K043019.

Who is the listed applicant for VASCULAR SOLUTIONS SCLERO-KIT?

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 VASCULAR SOLUTIONS SCLERO-KIT?

The FDA product code for VASCULAR SOLUTIONS SCLERO-KIT is FMI.

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Related Devices (Code: FMI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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