PathBuilder Steerable Introducer

FDA 510(k) K211530 · Shanghai Microport EP Medtech Co., Ltd.

Substantially Equivalent

510(k) numberK211530

Submission

Device name
PathBuilder Steerable Introducer
Applicant
Shanghai Microport EP Medtech Co., Ltd.
Shanghai, CN
Received
May 17, 2021
Decision date
February 8, 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
DYB – Introducer, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1340
Specialty
Cardiovascular

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More from Protaryx Medical, Inc.

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Questions and answers

When was PathBuilder Steerable Introducer cleared by the FDA?

PathBuilder Steerable Introducer (K211530) received a 510(k) decision of Substantially Equivalent on February 8, 2022, 267 days after the submission was received.

What is the product code of K211530?

The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.