PathBuilder Transseptal Guiding Introducer
K-Number: K212626 · 2022-03-23
Decision Date2022-03-23
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
PathBuilder Transseptal Guiding Introducer is a medical device manufactured by Shanghai Microport EP Medtech Co., Ltd.. It received FDA 510(k) clearance on 2022-03-23 under approval number K212626. 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 PathBuilder Transseptal Guiding Introducer?
PathBuilder Transseptal Guiding Introducer is a medical device that received FDA 510(k) clearance on 2022-03-23. It is manufactured by Shanghai Microport EP Medtech Co., Ltd.. The 510(k) number is K212626.
When was PathBuilder Transseptal Guiding Introducer approved by the FDA?
PathBuilder Transseptal Guiding Introducer received FDA 510(k) clearance on 2022-03-23, under approval number K212626.
What company makes PathBuilder Transseptal Guiding Introducer?
PathBuilder Transseptal Guiding Introducer is manufactured by Shanghai Microport EP Medtech Co., Ltd..
What is the FDA product code for PathBuilder Transseptal Guiding Introducer?
The FDA product code for PathBuilder Transseptal Guiding Introducer 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.