Cleared Traditional

K193653 - Hydrophilic Coating Guide Wire

K193653 is an FDA 510(k) clearance for Hydrophilic Coating Guide Wire, manufactured by Suzhou Hengrui Disheng Medical Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K193653 · Suzhou Hengrui Disheng Medical Co., Ltd. · Cardiovascular device
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Aug 2020
Decision
240d
Days
Class 2
Risk

K193653 is an FDA 510(k) clearance for the Hydrophilic Coating Guide Wire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Suzhou Hengrui Disheng Medical Co., Ltd. (Suzhou 215163, CN). The FDA issued a Cleared decision on August 26, 2020 after a review of 240 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Suzhou Hengrui Disheng Medical Co., Ltd. devices

FDA 510(k) Submission Details - K193653

510(k) Number K193653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2019
Decision Date August 26, 2020
Days to Decision 240 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
115d slower than avg
Panel avg: 125d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K193653.
LiPPS Analyzer, LiPPS Wire Pressure Guide Wire
K201720 · Beijing Bywave Sensing Medical Technology Co., Ltd. · Feb 2021
Merit Hydrophilic Guide Wire
K201595 · Merit Medical Systems, Inc. · Oct 2020
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
K202543 · Volcano Corporation · Sep 2020
HI-TORQUE PROCEED Guide Wire Family
K201834 · Abbott Vascular · Jul 2020
Zoom 14 Guidewire
K201760 · Scientia Vascular, LLC · Jul 2020
Mirage Hydrophilic Guidewire
K201690 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jul 2020