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Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Gu…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K161887

by Volcano Corporation

Identifiers

510(k) Number
K161887 FDA 510(k)
FDA Product Code
DQX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1330 FDA 510(k)
Regulation Number
870.1330 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Verrata PLUS Pressure Guide Wire is a coronary and peripheral pressure measurement catheter designed for diagnostic angiography and interventional procedures. It incorporates a high-fidelity sensor for accurate intravascular pressure assessment, enabling hemodynamic evaluation of blood vessel disease.

Available in four configurations—185 cm Straight Tip (.014”), 185 cm J-Tip (.014”), 300 cm Straight Tip, and 300 cm J-Tip—the device is supplied sterile and intended for single-use. It is MRI-unsafe and requires proper storage as per manufacturer guidelines. Authorized under FDA 510(k) clearance (K161887) and MDD compliance, it is distributed by Volcano Corporation.

Frequently asked questions

What types of procedures is the Verrata PLUS Pressure Guide Wire designed for, and how does its design support those uses?

The Verrata PLUS Pressure Guide Wire is designed for both coronary and peripheral diagnostic angiography and interventional procedures. Its high-fidelity pressure sensor enables precise intravascular pressure measurements, which are critical for evaluating blood vessel disease and guiding interventions. The four available configurations (185 cm Straight Tip, 185 cm J-Tip, 300 cm Straight Tip, and 300 cm J-Tip) cater to different anatomical needs, ensuring flexibility for navigating varied vascular pathways during procedures.

Is the Verrata PLUS Pressure Guide Wire reusable, and if not, how should it be handled after use to ensure safety?

The Verrata PLUS Pressure Guide Wire is explicitly intended for single-use only. After use, it should be discarded in accordance with standard medical device disposal protocols to prevent contamination and ensure patient safety. Its sterile packaging ensures sterility for one-time use, so reuse is not recommended or supported by the manufacturer.

What are the key differences between the Straight Tip and J-Tip versions of the Verrata PLUS Pressure Guide Wire, and how might a clinician choose between them?

The Straight Tip versions (185 cm and 300 cm) feature a linear design, ideal for precise navigation through straight or slightly tortuous vessels where direct advancement is required. The J-Tip versions (185 cm and 300 cm) have a curved distal end, which enhances maneuverability in complex or highly curved anatomy, such as the aortic arch or peripheral vessels. Clinicians typically select based on the specific vascular pathway and procedural requirements—Straight Tips for straightforward access, J-Tips for navigating bends or tight curves.

How should the Verrata PLUS Pressure Guide Wire be stored, and are there any special considerations for maintaining its performance?

The device must be stored as directed by the manufacturer to preserve sterility and functionality. It is supplied sterile, so unopened packaging should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is MRI-unsafe, it should never be used or stored in an MRI environment. Always follow the manufacturer’s guidelines for shelf-life and handling to ensure accurate pressure readings during procedures.

What regulatory pathways does the Verrata PLUS Pressure Guide Wire follow, and what does this mean for clinicians or purchasers?

The Verrata PLUS Pressure Guide Wire is authorized under FDA 510(k) clearance (K161887) and complies with the MDD (Medical Device Directive). This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device in the U.S. and meets essential safety and performance requirements in the EU. Clinicians and purchasers can rely on these authorizations as evidence of the device’s compliance with applicable standards, though local regulations may still apply depending on the region of use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Philips - Verrata Plus pressure guide wire - Philips, Verrata PLUS Pressure Guide Wire - Straight Tip - .014" x 185cm, PDF Instructions for Use Models: 10185p/10185jp • 10300p/10300jp English ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Volcano Corporation

Sources (2)

  • FDA 510(k) K161887 24 fields · synced Sep 20, 2026
  • EUDAMED 1 fields · synced May 19, 2026