Cleared Traditional

K151610 - Comet Pressure Guidewire

K151610 is the FDA 510(k) clearance for Comet Pressure Guidewire by Boston Scientific Corporation. It is a Class 2 Cardiovascular device (product code DXO) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K151610 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
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Oct 2015
Decision
113d
Days
Class 2
Risk

K151610 is an FDA 510(k) clearance for the Comet Pressure Guidewire. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Fremont, US). The FDA issued a Cleared decision on October 6, 2015 after a review of 113 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 Boston Scientific Corporation devices

Submission Details

510(k) Number K151610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2015
Decision Date October 06, 2015
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 24
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K151610.
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
TruWave Disposable Pressure Transducer
K142749 · Edwards Lifesciences, LLC · Jan 2015
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
K141495 · Edwards Lifesciences, LLC · Sep 2014
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
K113584 · St Jude Medical · Mar 2012