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FDA 510(k)

PathBuilder Transseptal Needle

K-Number: K212625 · 2022-03-23

ApplicantShanghai Microport EP Medtech Co., Ltd.
Decision Date2022-03-23
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PathBuilder Transseptal Needle 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 2022-03-23 under 510(k) number K212625. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PathBuilder Transseptal Needle?

PathBuilder Transseptal Needle is a medical device that received FDA 510(k) clearance on 2022-03-23. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. The 510(k) number is K212625.

When did PathBuilder Transseptal Needle receive FDA 510(k) clearance?

PathBuilder Transseptal Needle received FDA 510(k) clearance on 2022-03-23, under 510(k) number K212625.

Who is the listed applicant for PathBuilder Transseptal Needle?

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 Transseptal Needle?

The FDA product code for PathBuilder Transseptal Needle is DRC.

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

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.

K210313EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping CatheterK212626PathBuilder Transseptal Guiding IntroducerK211530PathBuilder Steerable Introducer

Related Devices (Code: DRC)

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.

K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)Synaptic Medical CorporationK241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLCK221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLCK210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLCK172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLCK172934Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, 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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