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FDA 510(k)

Eclipse 2L

K-Number: K183045 · 2019-04-30

ApplicantBalt USA, LLC
Decision Date2019-04-30
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Eclipse 2L is the device name listed in this FDA 510(k) record. The listed applicant is Balt USA, LLC. It received FDA 510(k) clearance on 2019-04-30 under 510(k) number K183045. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eclipse 2L?

Eclipse 2L is a medical device that received FDA 510(k) clearance on 2019-04-30. The listed applicant is Balt USA, LLC. The 510(k) number is K183045.

When did Eclipse 2L receive FDA 510(k) clearance?

Eclipse 2L received FDA 510(k) clearance on 2019-04-30, under 510(k) number K183045.

Who is the listed applicant for Eclipse 2L?

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

What is the FDA product code for Eclipse 2L?

The FDA product code for Eclipse 2L is MJN.

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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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