Optimus 0.035 PTA Balloon Dilatation Catheter
by Usci Ireland
510(k) K082646
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082646 | Date3 Nov 2008 | 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- Withdrawn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
- DQY
- 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 Optimus 0.035 PTA Balloon Dilatation Catheter is a percutaneous transluminal angioplasty (PTA) balloon catheter designed to dilate stenoses in peripheral arteries. It features a dual-lumen design, with one lumen for balloon inflation using contrast medium and the other for guidewire passage, enabling precise catheter navigation through narrowed arterial segments.
This device is supplied sterile and intended for single-use. It is classified under FDA product code DQY and cleared via the 510(k) pathway as a Class II medical device. The catheter is available in a 0.035-inch diameter configuration and must be stored according to manufacturer instructions to maintain sterility and functionality.
Other devices from Usci Ireland
Questions
AI-generated answers, 19 Sep 2026
What is the primary use of the Optimus 0.035 PTA Balloon Dilatation Catheter in clinical practice?
The Optimus 0.035 PTA Balloon Dilatation Catheter is specifically designed for percutaneous transluminal angioplasty (PTA), a procedure to widen narrowed or blocked peripheral arteries. Its dual-lumen design allows for simultaneous guidewire passage and balloon inflation using contrast medium, making it ideal for navigating and dilating stenoses in smaller arterial segments.
Is this catheter reusable, or is it intended for single-use only?
This device is intended for single-use only, as explicitly stated in the manufacturer’s instructions. It is supplied sterile, and reuse could compromise sterility and functionality, posing potential risks to patients.
What guidewire diameter does the Optimus 0.035 PTA Balloon Catheter accommodate, and why is this important?
The catheter is designed for use with a 0.035-inch diameter guidewire, which is a standard size in peripheral interventions. This compatibility ensures smooth navigation through tortuous anatomy and allows for precise placement at the target stenosis site, reducing procedural complexity.
How should I store this catheter to ensure it remains effective and sterile?
The catheter must be stored strictly according to the manufacturer’s instructions to preserve sterility and functionality. Improper storage—such as exposure to moisture, extreme temperatures, or physical damage—could compromise its integrity before use.
What regulatory pathway was used to clear this device, and what does that mean for its safety and performance?
The Optimus 0.035 PTA Balloon Catheter was cleared via the FDA’s 510(k) pathway under product code DQY, with a determination of Substantially Equivalent (SESE) to a predicate device. This means the FDA reviewed it as a Class II medical device and found it to have similar safety and performance characteristics to an existing approved product, ensuring it meets regulatory standards for peripheral angioplasty.