Morph DNA Steerable Introducer Sheath
K-Number: K242169 · 2024-08-23
ApplicantBiocardia
Decision Date2024-08-23
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Morph DNA Steerable Introducer Sheath is a medical device manufactured by Biocardia. It received FDA 510(k) clearance on 2024-08-23 under approval number K242169. 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 Morph DNA Steerable Introducer Sheath?
Morph DNA Steerable Introducer Sheath is a medical device that received FDA 510(k) clearance on 2024-08-23. It is manufactured by Biocardia. The 510(k) number is K242169.
When was Morph DNA Steerable Introducer Sheath approved by the FDA?
Morph DNA Steerable Introducer Sheath received FDA 510(k) clearance on 2024-08-23, under approval number K242169.
What company makes Morph DNA Steerable Introducer Sheath?
Morph DNA Steerable Introducer Sheath is manufactured by Biocardia.
What is the FDA product code for Morph DNA Steerable Introducer Sheath?
The FDA product code for Morph DNA Steerable Introducer Sheath is DYB.
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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.