Flex Scoring Catheter
510(k) K152789
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152789 | Date25 May 2016 | 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- Withdrawn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
- PNO
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Flex Scoring Catheter is a Catheter, Percutaneous, Cutting/Scoring designed to facilitate dilation of stenoses in peripheral arteries. It is intended for use with percutaneous transluminal angioplasty (PTA) catheters to mechanically score and cut atherosclerotic plaque, improving lumen diameter in the femoral and popliteal arteries, as well as arteriovenous dialysis fistulas. The device operates via a cutting/scoring mechanism to enhance vascular access and blood flow during interventional procedures.
This device is supplied as a single-use, non-sterile product (sterilized prior to use) and is classified under FDA product code PNO as a Class II medical device under 21 CFR 870.1250. It is intended for use in vascular interventional settings, including hemodialysis access management. The Flex Scoring Catheter received FDA 510(k) clearance (K152789) under the Traditional 510(k) Review Process, with a decision date of May 25, 2016. No MRI safety information is specified, and storage conditions are not detailed in the regulatory submission.
Other devices from Venturemed Group, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Flex Scoring Catheter used for?
The Flex Scoring Catheter is designed to mechanically score and cut atherosclerotic plaque within stenosed peripheral arteries. This process helps enlarge the lumen diameter, facilitating better blood flow during percutaneous transluminal angioplasty (PTA) procedures. It is specifically intended for use in the femoral and popliteal arteries, as well as arteriovenous dialysis fistulas, to improve vascular access and hemodialysis efficiency.
How is the Flex Scoring Catheter supplied and prepared for use?
The Flex Scoring Catheter is supplied as a single-use device and is non-sterile at the time of shipment. It must be sterilized prior to use, as indicated in the product documentation. This ensures safety and compliance with clinical standards before deployment in interventional procedures.
Is the Flex Scoring Catheter reusable, or is it intended for one-time use?
The Flex Scoring Catheter is explicitly designed for single-use only. After a single procedure, it should not be reused to maintain patient safety and device efficacy. Single-use devices are engineered to minimize infection risks and ensure consistent performance.
What types of arteries or vascular sites can the Flex Scoring Catheter treat?
The Flex Scoring Catheter is intended for use in the femoral and popliteal arteries, as well as arteriovenous dialysis fistulas. These sites are commonly affected by atherosclerotic plaque buildup, which can restrict blood flow and require mechanical intervention to restore proper function.
Are there any specific storage instructions provided for the Flex Scoring Catheter?
The regulatory submission does not detail specific storage conditions for the Flex Scoring Catheter. However, standard medical device storage practices—such as protecting from contamination, extreme temperatures, and physical damage—should be followed until sterilization and immediate use. Always refer to the manufacturer’s instructions for complete guidance.