FDA 510(k)

VESSEL GUARDIAN

K-Number: K102136 · 2010-09-27

Decision Date2010-09-27

Product CodeHIF

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

VESSEL GUARDIAN is the device name listed in this FDA 510(k) record. The listed applicant is Lexion Medical, LLC. It received FDA 510(k) clearance on 2010-09-27 under 510(k) number K102136. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VESSEL GUARDIAN?

VESSEL GUARDIAN is a medical device that received FDA 510(k) clearance on 2010-09-27. The listed applicant is Lexion Medical, LLC. The 510(k) number is K102136.

When did VESSEL GUARDIAN receive FDA 510(k) clearance?

VESSEL GUARDIAN received FDA 510(k) clearance on 2010-09-27, under 510(k) number K102136.

Who is the listed applicant for VESSEL GUARDIAN?

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

What is the FDA product code for VESSEL GUARDIAN?

The FDA product code for VESSEL GUARDIAN is HIF.

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Other records listing Lexion Medical, LLC as applicant

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Related Devices (Code: HIF)

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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.