Catheter Balloon Dilator Pressure Gauge
by Argon Medical Corp. 510(k)
Active
510(k) K895511
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895511 | Date28 Feb 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
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, 28 Sep 2026
A catheter balloon dilator pressure gauge is a device used to measure and monitor the inflation pressure of balloon catheters during vascular procedures. It is classified as a Class II medical device under FDA regulation 870.1650 and has the product code MAV.
The device received traditional 510(k) clearance (K895511) from Argon Medical Corp. on February 28, 1990, following submission on September 12, 1989. It is intended for use in cardiovascular applications and is supplied as a non-sterile, reusable pressure monitoring component for balloon dilation systems.
Other devices from Argon Medical Corp.
Questions
AI-generated answers, 28 Sep 2026
What is the CATHETER BALLOON DILATOR PRESSURE GAUGE used for?
It is used to measure and monitor the inflation pressure of balloon catheters during vascular procedures, ensuring accurate pressure control in cardiovascular applications.
Is the CATHETER BALLOON DILATOR PRESSURE GAUGE sterile or non-sterile, and is it reusable?
The device is supplied as a non-sterile component and is designed for reuse, meaning it must be cleaned and sterilized by the user before each use according to institutional protocols.
What regulatory pathway was used for the CATHETER BALLOON DILATOR PRESSURE GAUGE, and what is its classification?
The device received traditional 510(k) clearance (K895511) from the FDA and is classified as a Class II medical device under regulation 870.1650 with product code MAV.