PathBuilder Transseptal Needle

FDA 510(k) K212625 · Shanghai Microport EP Medtech Co., Ltd.

Substantially Equivalent

510(k) numberK212625

Submission

Device name
PathBuilder Transseptal Needle
Applicant
Shanghai Microport EP Medtech Co., Ltd.
Shanghai, CN
Received
August 18, 2021
Decision date
March 23, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRC – Trocar
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1390
Specialty
Cardiovascular

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K210328SafeSept Blunt NeedleDRC · Special Pressure Products Medical Device Manufacturing…03/05/2021SE
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K172934Needle Free Transseptal CannulaDRC · Traditional Pressure Products Medical Device Manufacturing…02/16/2018SE
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K170671SafeSept Transseptal GuidewireDRC · Traditional Pressure Products Medical Device Manufacturing…10/20/2017SE
K132943Intracardic Catheter Introducer Kit and Transseptal NeedleDRC · Traditional Synaptic Medical Limited08/29/2014SE
K130843Safesept Needle Free Transseptal Trocar GuidewireDRC · Traditional Oscor, Inc.01/08/2014SE

More from Oscor, Inc.

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K210313EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping CatheterDRF · Traditional 12/30/2022SE
K212626PathBuilder Transseptal Guiding IntroducerDYB · Traditional 03/23/2022SE
K211530PathBuilder Steerable IntroducerDYB · Traditional 02/08/2022SE

Questions and answers

When was PathBuilder Transseptal Needle cleared by the FDA?

PathBuilder Transseptal Needle (K212625) received a 510(k) decision of Substantially Equivalent on March 23, 2022, 217 days after the submission was received.

What is the product code of K212625?

The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.