14Fr Low Profile Introducer Kit
K-Number: K252766 · 2025-10-08
ApplicantAbiomed, Inc.
Decision Date2025-10-08
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
14Fr Low Profile Introducer Kit is a medical device manufactured by Abiomed, Inc.. It received FDA 510(k) clearance on 2025-10-08 under approval number K252766. 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 14Fr Low Profile Introducer Kit?
14Fr Low Profile Introducer Kit is a medical device that received FDA 510(k) clearance on 2025-10-08. It is manufactured by Abiomed, Inc.. The 510(k) number is K252766.
When was 14Fr Low Profile Introducer Kit approved by the FDA?
14Fr Low Profile Introducer Kit received FDA 510(k) clearance on 2025-10-08, under approval number K252766.
What company makes 14Fr Low Profile Introducer Kit?
14Fr Low Profile Introducer Kit is manufactured by Abiomed, Inc..
What is the FDA product code for 14Fr Low Profile Introducer Kit?
The FDA product code for 14Fr Low Profile Introducer Kit 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.