Cleared Traditional

PathBuilder Steerable Introducer

K211530 · Shanghai Microport EP Medtech Co., Ltd. · Cardiovascular
Feb 2022
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K211530 is an FDA 510(k) clearance for the PathBuilder Steerable Introducer, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Shanghai Microport EP Medtech Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 8, 2022, 267 days after receiving the submission on May 17, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K211530 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2021
Decision Date February 08, 2022
Days to Decision 267 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340