Echo Large Bore Introducer Sheath
K-Number: K260606 · 2026-04-29
ApplicantEcho Medical, LLC
Decision Date2026-04-29
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Echo Large Bore Introducer Sheath is a medical device manufactured by Echo Medical, LLC. It received FDA 510(k) clearance on 2026-04-29 under approval number K260606. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Echo Large Bore Introducer Sheath?
Echo Large Bore Introducer Sheath is a medical device that received FDA 510(k) clearance on 2026-04-29. It is manufactured by Echo Medical, LLC. The 510(k) number is K260606.
When was Echo Large Bore Introducer Sheath approved by the FDA?
Echo Large Bore Introducer Sheath received FDA 510(k) clearance on 2026-04-29, under approval number K260606.
What company makes Echo Large Bore Introducer Sheath?
Echo Large Bore Introducer Sheath is manufactured by Echo Medical, LLC.
What is the FDA product code for Echo Large Bore Introducer Sheath?
The FDA product code for Echo Large Bore Introducer Sheath is DYB.
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.