Cleared Traditional

K151234 - R350 guidewire

K151234 is the FDA 510(k) clearance for R350 guidewire by Vascular Solutions, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K151234 · Vascular Solutions, Inc. · Cardiovascular device
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Nov 2015
Decision
194d
Days
Class 2
Risk

K151234 is an FDA 510(k) clearance for the R350 guidewire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 18, 2015 after a review of 194 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 Vascular Solutions, Inc. devices

Submission Details

510(k) Number K151234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2015
Decision Date November 18, 2015
Days to Decision 194 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
69d slower than avg
Panel avg: 125d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 381
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K151234.
ASAHI Astato XS 40
K153443 · Asahi Intecc Co., Ltd. · Feb 2016
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
K152231 · Boston Scientific Corporation · Feb 2016
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
K151840 · Boston Scientific Corporation · Dec 2015
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
K150445 · Asahi Intecc Co., Ltd. · Jun 2015
Heavy Double Flexible Tipped Wire Guide
K150802 · Cook Incorporated · May 2015
Attain Hybrid Guide Wire
K143316 · Medtronic, Inc. · Mar 2015