Cleared Traditional

K192454 - Wattson Temporary Pacing Guidewire

K192454 is an FDA 510(k) clearance for Wattson Temporary Pacing Guidewire, manufactured by Vascular Solutions. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K192454 · Vascular Solutions · Cardiovascular device
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Jan 2020
Decision
128d
Days
Class 2
Risk

K192454 is an FDA 510(k) clearance for the Wattson Temporary Pacing Guidewire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Vascular Solutions (Minneapolis, US). The FDA issued a Cleared decision on January 15, 2020 after a review of 128 days - within the typical 510(k) review window.

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 Vascular Solutions devices

FDA 510(k) Submission Details - K192454

510(k) Number K192454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2019
Decision Date January 15, 2020
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQX Wire, Guide, Catheter

All 684
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K192454.
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OptoWire III
K191907 · Opsens, Inc. · Jan 2020
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K192599 · Asahi Intecc Co., Ltd. · Jan 2020
CrossTorq 14 Guidewire
K193194 · Scientia Cardio Access, LLC · Dec 2019