Basixconpak Analog Inflation Syringe
by Merit Medical Ireland, Ltd.
510(k) K122321
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122321 | Date19 Dec 2012 | StatusActive |
Recalls
-
- Terminated Z-0002-2017
Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MAV
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1650
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The BasixCompak Analog Inflation Syringe is a Syringe, Balloon Inflation (per FDA nomenclature), designed for controlled inflation and deflation of dilation balloons. It provides precise pressure control for medical procedures, including biliary dilation, with a maximum pressure output of 30 ATM/bars. The device features a threaded plunger assembly with a lock/release bar and a flexible high-pressure extension tube to ensure safe and accurate inflation dynamics.
This single-use, disposable device is supplied as a sterile, pre-packaged unit and is intended for use in clinical settings requiring precise inflation control. It includes a three-way medium pressure stopcock for added operational flexibility. The device is classified as Class II under FDA regulations (870.1650) and has received FDA 510K clearance as substantially equivalent to predicate devices. No MRI safety considerations are specified, and storage should follow standard sterile medical device protocols.
Other devices from Merit Medical Ireland, Ltd.
Questions
AI-generated answers, 19 Sep 2026
What types of medical procedures is the BasixCompak Analog Inflation Syringe specifically designed to support with its precise pressure control?
The BasixCompak Analog Inflation Syringe is designed for controlled inflation and deflation of dilation balloons, particularly in procedures requiring precise pressure control such as biliary dilation. Its maximum pressure output of 30 ATM/bars ensures accurate inflation dynamics for these specialized applications.
Is the BasixCompak Analog Inflation Syringe reusable or intended for single-use, and how is it packaged?
The BasixCompak Analog Inflation Syringe is a single-use, disposable device. It is supplied as a sterile, pre-packaged unit, ensuring it is ready for immediate clinical use without the need for reprocessing.
What features does the BasixCompak Analog Inflation Syringe include to enhance operational flexibility during use?
The device includes a threaded plunger assembly with a lock/release bar for secure control and a flexible high-pressure extension tube for safe inflation dynamics. Additionally, it features a three-way medium pressure stopcock, which provides added operational flexibility during procedures.
How should the BasixCompak Analog Inflation Syringe be stored, and what are the implications of its sterility?
The device should be stored following standard sterile medical device protocols. Since it is supplied as a sterile, pre-packaged unit, it is crucial to maintain its sterility until use to ensure patient safety and prevent contamination.
Are there any specific safety considerations related to MRI compatibility for the BasixCompak Analog Inflation Syringe?
The device documentation does not specify any MRI safety considerations, meaning it may not be explicitly tested or labeled for use in MRI environments. Clinicians should verify compatibility with their specific MRI equipment and protocols before use.