Identifiers
- 510(k) Number
- K193466 FDA 510(k)
- FDA Product Code
- DYG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1240 FDA 510(k)
- Regulation Number
- 870.1240 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Swan-Ganz Catheters are pulmonary artery catheters intended for short-term use in the central circulatory system for patients who require intracardiac hemodynamic monitoring, blood sampling, and infusing solutions. They provide continuous parameters on flow, pressure, and oxygen delivery and consumption for a comprehensive hemodynamic profile when used with a compatible cardiac output monitor.
These devices are supplied by Edwards Lifesciences LLC and are classified as Class II medical devices under FDA regulation number 870.1240 with product code DYG. They received FDA 510(k) clearance (K193466) on February 16, 2020, as substantially equivalent to a predicate device. The catheters are designed for single-use, short-term hemodynamic monitoring in clinical settings.
Frequently asked questions
What is the Swan-Ganz Catheter used for?
The Swan-Ganz Catheter is intended for short-term use in the central circulatory system to monitor intracardiac hemodynamics, enabling continuous measurement of flow, pressure, and oxygen delivery and consumption for a comprehensive hemodynamic profile when paired with a compatible cardiac output monitor.
Is the Swan-Ganz Catheter reusable or single-use?
The Swan-Ganz Catheter is designed for single-use only, as stated in the device description, to ensure patient safety and prevent cross-contamination during short-term hemodynamic monitoring in clinical settings.
Who manufactures the Swan-Ganz Catheter and where are they located?
The Swan-Ganz Catheter is manufactured by Edwards Lifesciences LLC, located at One Edwards Way, Irvine, CA 92614, United States, as specified in the device authorization data.
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: Swan-Ganz Catheters | Edwards Lifesciences, PDF Swan-Ganz - eifu.edwards.com, Swan-Ganz™ IQ Pulmonary Artery Catheters | BD, PDF Swan-Ganz True Size Thermodilution Catheters Models 131F7, 131F7J, & 151F7
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193466 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA 510(k) K193466 24 fields · synced Oct 6, 2026