Cleared Traditional

PathBuilder Transseptal Guiding Introducer

K212626 · Shanghai Microport EP Medtech Co., Ltd. · Cardiovascular
Mar 2022
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K212626 is an FDA 510(k) clearance for the PathBuilder Transseptal Guiding 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 March 23, 2022, 217 days after receiving the submission on August 18, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K212626 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2021
Decision Date March 23, 2022
Days to Decision 217 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