FirstStic N Introducer
by Argon Medical Devices, Inc.
510(k) K141969
Active
Valid until
No date given
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK141969 | Date19 Dec 2014 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- DYB
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1340
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The FirstStic N Introducer is a vascular introducer designed for percutaneous access procedures. It facilitates the insertion of guidewires and catheters into blood vessels, providing a stable pathway for interventional cardiology and related procedures.
This device is supplied sterile and intended for single-use. It is classified under product code DYB and has received FDA 510(k) clearance and MDD authorization. The introducer is available in specific sizes as detailed in its specifications, and proper handling and storage are essential to maintain sterility and functionality.
Other devices from Argon Medical Devices, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of medical procedures is the FirstStic N Introducer primarily used for?
The FirstStic N Introducer is designed specifically for percutaneous access procedures in interventional cardiology. It creates a stable pathway in blood vessels to facilitate the insertion of guidewires and catheters, making it essential for procedures like coronary angiography, angioplasty, or other vascular interventions where controlled access is critical.
Is the FirstStic N Introducer meant for repeated use, or is it single-use only?
The FirstStic N Introducer is explicitly intended for single-use only. It is supplied sterile, and reuse could compromise sterility and functionality, potentially leading to complications during procedures. Always follow manufacturer guidelines to ensure patient safety.
What sizes are available for the FirstStic N Introducer, and how do I choose the right one?
The FirstStic N Introducer comes in specific sizes as detailed in its specifications (though exact measurements are not provided here). Selection depends on the patient’s vascular anatomy and the intended procedure—typically, larger vessels require larger introducers for stable catheter placement. Consult the device’s labeling or manufacturer guidance for precise sizing recommendations.
How should I store the FirstStic N Introducer to maintain its sterility and performance?
Proper storage is critical to preserve sterility and functionality. The device should be stored in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination by keeping it protected until immediate use, as it is not designed for long-term storage outside its packaging.
What regulatory pathways has the FirstStic N Introducer followed, and what does that mean for me?
The FirstStic N Introducer has received FDA 510(k) clearance under the Traditional pathway, demonstrating it is substantially equivalent to a legally marketed predicate device. It also holds MDD authorization, indicating compliance with European medical device regulations. This means it meets U.S. and EU standards for safety and performance, but always verify local compliance requirements before use.