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 a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2019-03-21 under approval 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. It is manufactured by Balt USA, LLC. The 510(k) number is K182918.
When was Ballast 088 Long Sheath approved by the FDA?
Ballast 088 Long Sheath received FDA 510(k) clearance on 2019-03-21, under approval number K182918.
What company makes Ballast 088 Long Sheath?
Ballast 088 Long Sheath is manufactured by Balt USA, LLC.
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.