Amethyst HP PTA OTW 0.035 Catheter
by Natec Medical Ltd 2 variants
510(k) K241040
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241040 | Date18 Dec 2024 | 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- Withdrawn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
- LIT
- FDA applicant
- Natec Medical , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Amethyst HP PTA OTW 0.035 Catheter is a peripheral, transluminal angioplasty catheter designed for the dilation of peripheral arterial lesions. It employs a high-pressure balloon system to mechanically widen narrowed or obstructed arteries, improving blood flow in peripheral vascular conditions.
This catheter is supplied as a single-use, over-the-wire (OTW) device with a shaft length of 75 cm and a balloon size of 7.00 x 80 mm. It is intended for use in controlled clinical settings, such as catheterization labs, and is classified as a Class II medical device under FDA regulations (870.1250). The device holds an FDA 510(k) clearance (K241040) and is distributed commercially.
Other devices from Natec Medical Ltd
Questions
AI-generated answers, 19 Sep 2026
What is the primary use of the Amethyst HP PTA OTW 0.035 Catheter in clinical practice?
The Amethyst HP PTA OTW 0.035 Catheter is specifically designed for peripheral transluminal angioplasty, meaning it mechanically widens narrowed or obstructed arteries to restore blood flow in peripheral vascular conditions. It uses a high-pressure balloon system to dilate lesions, making it suitable for treating arterial blockages in controlled settings like catheterization labs.
Is this catheter intended for single-use or repeated use, and how should it be stored?
The Amethyst HP PTA OTW 0.035 Catheter is single-use only, as explicitly stated in its specifications. Since it’s a sterile medical device, it should be stored in its original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures, to preserve sterility and functionality until use.
What are the key dimensions of the catheter, and how does the balloon size relate to its application?
The catheter features a 75 cm shaft length and a 7.00 x 80 mm balloon, where the 7.00 mm refers to the balloon’s diameter and 80 mm to its length. This sizing allows for precise dilation of peripheral arteries, ensuring compatibility with common vascular access routes while providing sufficient expansion force to treat moderate to severe stenosis in lower-extremity arteries.
How is this device regulated, and what does the FDA clearance indicate about its safety and effectiveness?
The Amethyst HP PTA OTW 0.035 Catheter holds an FDA 510(k) clearance (K241040), meaning it has been determined to be substantially equivalent to a legally marketed predicate device. This clearance does not imply approval for specific clinical outcomes but confirms that the device meets FDA standards for safety and performance based on comparative data. It is classified under FDA product code LIT and falls under the Cardiovascular (CV) advisory committee for regulatory oversight.