Cleared Traditional

Endura guidewire (K161702) - FDA 510(k) Clearance

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

K161702 · Vascular Solutions, Inc. · Cardiovascular device
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Dec 2016
Decision
169d
Days
Class 2
Risk

K161702 is an FDA 510(k) clearance for the Endura 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 December 6, 2016 after a review of 169 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 K161702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2016
Decision Date December 06, 2016
Days to Decision 169 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
44d slower than avg
Panel avg: 125d · This submission: 169d
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 380
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K161702.
Inqwire Diagnostic Guide Wire
K163575 · Merit Medical Systems, Inc. · Mar 2017
ASAHI PTCA Guide Wire ASAHI SUOH 03
K162842 · Asahi Intecc Co., Ltd. · Jan 2017
Spectre guidewire
K163444 · Vascular Solutions, Inc. · Jan 2017
ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
K161584 · Asahi Intecc Co., Ltd. · Oct 2016
ASAHI Fielder XT-A, ASAHI Fielder XT-R
K153106 · Asahi Intecc Co., Ltd. · Jun 2016
ASAHI Astato XS 40
K153443 · Asahi Intecc Co., Ltd. · Feb 2016