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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 the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. It received FDA 510(k) clearance on 2022-02-08 under 510(k) 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. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. The 510(k) number is K211530.

When did PathBuilder Steerable Introducer receive FDA 510(k) clearance?

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

Who is the listed applicant for PathBuilder Steerable Introducer?

The FDA 510(k) record lists Shanghai Microport EP Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PathBuilder Steerable Introducer?

The FDA product code for PathBuilder Steerable Introducer is DYB.

Related Clinical Trials

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NCT07720557PulseMagic™ TrueForce™ PAF NMPA StudyNOT_YET_RECRUITING

Other records listing Shanghai Microport EP Medtech Co., Ltd. as applicant

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Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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