Schneider-Shiley SofTrac-PTA Angio. Catheter
510(k) K872542
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872542 | Date14 Sep 1987 | 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- Withdrawn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
- Full name
- Schneider-Shiley Softrac-PTA(Tm) Angio. Catheter
- 510(k) Number
- FDA Product Code
- LIT
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Schneider-Shiley SofTrac-PTA Angio. Catheter is a peripheral, transluminal angioplasty catheter designed for use in vascular interventions. It is classified under product code LIT and falls under the category of Catheter, Angioplasty, Peripheral, Transluminal, as defined by regulatory authorities. This device is intended for dilation of peripheral arteries to restore blood flow, typically in the lower extremities or other peripheral vascular sites.
This catheter is supplied as a single-use medical device and is regulated under FDA 510(k) clearance (K872542) as a Class II device under special controls. It is intended for use in clinical settings such as catheterization labs or interventional radiology suites. The device is non-sterile prior to packaging and must be sterilized by the manufacturer before use. No specific MRI safety information is provided, and its dimensions or additional technical specifications are not detailed in the available data.
Other devices from Angiomedics, Inc.
Questions
AI-generated answers, 20 Sep 2026
What is the primary clinical use of the Schneider-Shiley SofTrac-PTA Angio. Catheter?
The Schneider-Shiley SofTrac-PTA Angio. Catheter is designed specifically for peripheral, transluminal angioplasty, meaning it is used to dilate narrowed or blocked arteries in peripheral vascular sites—most commonly the lower extremities—to restore blood flow. It is intended for use in vascular interventions within clinical settings like catheterization labs or interventional radiology suites.
Is this catheter intended for reuse, or is it a single-use device?
The Schneider-Shiley SofTrac-PTA Angio. Catheter is explicitly labeled as a single-use medical device. This means it should not be reused after a single procedure to ensure patient safety and sterility.
How is the catheter supplied, and what sterilization process is required before use?
The catheter is supplied in a non-sterile state prior to packaging. According to the manufacturer’s instructions, it must undergo sterilization by the manufacturer before it can be used in clinical settings. This ensures it meets regulatory standards for safety and infection control.
What regulatory pathway was followed for FDA clearance of this device?
The Schneider-Shiley SofTrac-PTA Angio. Catheter received FDA 510(k) clearance under the traditional review pathway, classified as a Class II device with special controls. The clearance number is K872542, and the device falls under the product code LIT for peripheral angioplasty catheters. The submission was reviewed by the Cardiovascular (CV) Advisory Committee in 1987.
Are there any available details on the catheter’s dimensions or specific models?
The provided data does not include specific dimensions, sizes, or model variations for the Schneider-Shiley SofTrac-PTA Angio. Catheter. However, the device is listed under multiple FEI numbers (e.g., 3011471056, 3011142981), which may correspond to different configurations or lot numbers, but no technical specifications are detailed in the available records.