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FDA 510(k)

VARI-LASE ENDOVENOUS LASER PROCEDURE KIT

K-Number: K051287 · 2005-07-29

ApplicantVascular Solutions, Inc.
Decision Date2005-07-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VARI-LASE ENDOVENOUS LASER PROCEDURE 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 2005-07-29 under 510(k) number K051287. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARI-LASE ENDOVENOUS LASER PROCEDURE KIT?

VARI-LASE ENDOVENOUS LASER PROCEDURE KIT is a medical device that received FDA 510(k) clearance on 2005-07-29. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K051287.

When did VARI-LASE ENDOVENOUS LASER PROCEDURE KIT receive FDA 510(k) clearance?

VARI-LASE ENDOVENOUS LASER PROCEDURE KIT received FDA 510(k) clearance on 2005-07-29, under 510(k) number K051287.

Who is the listed applicant for VARI-LASE ENDOVENOUS LASER PROCEDURE 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 VARI-LASE ENDOVENOUS LASER PROCEDURE KIT?

The FDA product code for VARI-LASE ENDOVENOUS LASER PROCEDURE KIT is GEX. This falls under the Gastroenterology category.

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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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