Cleared Traditional

PathBuilder Steerable Introducer (K211530) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K211530 is an FDA 510(k) clearance for the PathBuilder Steerable Introducer. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Shanghai Microport EP Medtech Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 8, 2022 after a review of 267 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Shanghai Microport EP Medtech Co., Ltd. devices

Submission Details

510(k) Number K211530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 125d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 272
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K211530.
Intri24 Sheath
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K213492 · Dib Ultranav Medical, LLC · Mar 2022
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K212626 · Shanghai Microport EP Medtech Co., Ltd. · Mar 2022
AcQCross Qx Integrated Transseptal Dilator/Needle
K220047 · Acutus Medical, Inc. · Feb 2022
Prelude IDeal 9F Hydrophilic Sheath Introducer
K212152 · Merit Medical Systems · Jan 2022
Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)
K213638 · Argon Medical Devices · Dec 2021