Merit RadialFlo Arterial Catheter
by Merit Medical Singapore Pte., Ltd.
510(k) K182538
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182538 | Date16 Jan 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FOZ
- FDA applicant
- Merit Medical Singapore Pte. , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Merit RadialFlo Arterial Catheter is an intravascular catheter designed to access the vasculature to sample blood and monitor blood pressure. It is a first-step device in setting up a pressure monitoring and closed blood sampling system, engineered for peripheral access to the arterial system to gather hemodynamic data.
The device is supplied by Merit Medical Singapore Pte. Ltd. and has received FDA 510(k) clearance under K182538. It is classified as a Class II medical device with product code FOZ and regulation number 21 CFR 880.5200. The device is intended for use in general hospital settings for arterial access and hemodynamic monitoring.
Other devices from Merit Medical Singapore Pte., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Merit RadialFlo Arterial Catheter used for?
The Merit RadialFlo Arterial Catheter is designed to access the vasculature to sample blood and monitor blood pressure. It serves as a first-step device in setting up a pressure monitoring and closed blood sampling system, engineered for peripheral access to the arterial system to gather hemodynamic data in general hospital settings.
How is the Merit RadialFlo Arterial Catheter supplied and what is its regulatory status?
The Merit RadialFlo Arterial Catheter is supplied by Merit Medical Singapore Pte. Ltd. and has received FDA 510(k) clearance under K182538. It is classified as a Class II medical device with product code FOZ and regulation number 21 CFR 880.5200, determined to be substantially equivalent through an abbreviated review process.
Is the Merit RadialFlo Arterial Catheter intended for single-use or reuse?
The device data does not specify whether the Merit RadialFlo Arterial Catheter is intended for single-use or reuse. As an intravascular catheter designed for arterial access and hemodynamic monitoring, it is typically used as a single-use device in clinical practice to prevent cross-contamination, but the provided information does not explicitly state this detail.