Cleared Traditional

K161171 - PressureWire X Guidewire

K161171 is an FDA 510(k) clearance for PressureWire X Guidewire, manufactured by St. Jude Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K161171 · St. Jude Medical, Inc. · Cardiovascular device
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Aug 2016
Decision
111d
Days
Class 2
Risk

K161171 is an FDA 510(k) clearance for the PressureWire X Guidewire. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by St. Jude Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 15, 2016 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - 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 St. Jude Medical, Inc. devices

FDA 510(k) Submission Details - K161171

510(k) Number K161171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2016
Decision Date August 15, 2016
Days to Decision 111 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
14d faster than avg
Panel avg: 125d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXO Device Classification - Class 2, Special Controls

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
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 - DXO Transducer, Pressure, Catheter Tip

All 39
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K161171.
TruWave Disposable Pressure Transducer
K183413 · Edwards Lifeciences, LLC · May 2019
PressureWire X
K180558 · St. Jude Medical (Now Part of Abbott Medical) · Mar 2018
TruWave Disposable Pressure Transducer
K171996 · Edwards Lifesciences, LLC · Oct 2017
Comet Pressure Guidewire
K151610 · Boston Scientific Corporation · Oct 2015
TruWave Disposable Pressure Transducer
K142749 · Edwards Lifesciences, LLC · Jan 2015
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
K141495 · Edwards Lifesciences, LLC · Sep 2014