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FDA 510(k)

Ballast 088 Long Sheath

K-Number: K182918 · 2019-03-21

ApplicantBalt USA, LLC
Decision Date2019-03-21
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ballast 088 Long Sheath 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 2019-03-21 under 510(k) number K182918. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ballast 088 Long Sheath?

Ballast 088 Long Sheath is a medical device that received FDA 510(k) clearance on 2019-03-21. The listed applicant is Balt USA, LLC. The 510(k) number is K182918.

When did Ballast 088 Long Sheath receive FDA 510(k) clearance?

Ballast 088 Long Sheath received FDA 510(k) clearance on 2019-03-21, under 510(k) number K182918.

Who is the listed applicant for Ballast 088 Long Sheath?

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 Ballast 088 Long Sheath?

The FDA product code for Ballast 088 Long Sheath is DQY.

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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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