Opto Wire and OptoMonitor System
FDA 510(k)Class II (US FDA 510(k))
by Opsens Inc.
Identifiers
- 510(k) Number
- K142598 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 Opto Wire and OptoMonitor System is a pressure guidewire combination device intended for intravascular blood pressure measurement, including fractional flow reserve (FFR) and differential pressure ratio (dPR) measurements. It is designed to be used or supervised by cardiologists in catheterization laboratories.
The system connects to a Cathlab Hemodynamic System or aortic transducer for operation. It is supplied as part of the OptoMonitor 3 system and is intended for single-use applications. The device has received FDA 510(k) clearance with the product code DQX and is classified under the cardiovascular advisory committee.
Frequently asked questions
What is the Opto Wire and OptoMonitor System used for?
The Opto Wire and OptoMonitor System is a pressure guidewire combination device designed for intravascular blood pressure measurement, including fractional flow reserve (FFR) and differential pressure ratio (dPR) measurements. It is intended to be used or supervised by cardiologists in catheterization laboratories.
How is the Opto Wire and OptoMonitor System supplied?
The system is supplied as part of the OptoMonitor 3 system and is intended for single-use applications. It connects to a Cathlab Hemodynamic System or aortic transducer for operation during procedures.
What is the regulatory status of the Opto Wire and OptoMonitor System?
The device has received FDA 510(k) clearance with the product code DQX and is classified under the cardiovascular advisory committee. It was determined to be substantially equivalent to predicate devices through the traditional clearance pathway.
Who should use the Opto Wire and OptoMonitor System?
The system is designed to be used or supervised by cardiologists in catheterization laboratories. These trained medical professionals are qualified to perform the intravascular blood pressure measurements and interpret the results for patient assessment.
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: OptoMonitor 3 - Opsens Medical, PDF Instructions for Use - Opsens Medical, Opsens, Inc. FDA 510(k) Cardiovascular Products - Latest 2026, Opto Wire and OptoMonitor System (K142598) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142598 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Opsens Inc.
- FDA Applicant
- Opsens, Inc.
Sources (1)
- FDA 510(k) K142598 24 fields · synced Sep 27, 2026