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FDA 510(k)

PathBuilder Steerable Introducer

K-Number: K211530 · 2022-02-08

ApplicantShanghai Microport EP Medtech Co., Ltd.
Decision Date2022-02-08
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PathBuilder Steerable Introducer is a medical device manufactured by Shanghai Microport EP Medtech Co., Ltd.. It received FDA 510(k) clearance on 2022-02-08 under approval number K211530. 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 Steerable Introducer?

PathBuilder Steerable Introducer is a medical device that received FDA 510(k) clearance on 2022-02-08. It is manufactured by Shanghai Microport EP Medtech Co., Ltd.. The 510(k) number is K211530.

When was PathBuilder Steerable Introducer approved by the FDA?

PathBuilder Steerable Introducer received FDA 510(k) clearance on 2022-02-08, under approval number K211530.

What company makes PathBuilder Steerable Introducer?

PathBuilder Steerable Introducer is manufactured by Shanghai Microport EP Medtech Co., Ltd..

What is the FDA product code for PathBuilder Steerable Introducer?

The FDA product code for PathBuilder Steerable Introducer is DYB.

Related Clinical Trials

NCT06106594 VOLT CE Mark Study ACTIVE_NOT_RECRUITING NCT06223789 VOLT-AF IDE Clinical Study COMPLETED

Other Devices by Shanghai Microport EP Medtech Co., Ltd.

K210313EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter K212625PathBuilder Transseptal Needle K212626PathBuilder Transseptal Guiding Introducer

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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.

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