Cleared Special

K161887 - Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip

K161887 is an FDA 510(k) clearance for Verrata PLUS Pressure Guide Wire, manufactured by Volcano Corporation. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 71-day FDA review.

K161887 · Volcano Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
71d
Days
Class 2
Risk

K161887 is an FDA 510(k) clearance for the Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure .... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on September 20, 2016 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Volcano Corporation devices

FDA 510(k) Submission Details - K161887

510(k) Number K161887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2016
Decision Date September 20, 2016
Days to Decision 71 days
Submission Type Special
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
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

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. 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 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K161887.
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K160018 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Jun 2016