True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20MM x 4.5CM
510(k) K121083
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121083 | Date11 Oct 2012 | StatusActive |
Recalls
-
- Terminated Z-1566-2013
Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time is 10 seconds maximum.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20mm X 4.5cm, True Dilatation Percutaneous Translumina
- 510(k) Number
- FDA Product Code
- OZT
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1255
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The True Dilatation Percutaneous Transluminal Valvuloplasty Catheter is a balloon aortic valvuloplasty device designed for dilation of stenotic aortic valves. It is a coaxial catheter with a fixed balloon at the tip, intended for percutaneous intervention to improve blood flow through narrowed aortic valves.
This device is supplied as a single-use, non-sterile catheter requiring sterilisation prior to use. It is positioned using a guidewire and inflated via radiopaque contrast media delivered through a syringe inflation device. The catheter is classified under FDA device class II (OZT product code) and holds an FDA 510K clearance for traditional review. It is regulated under 21 CFR 870.1255 and is intended for use in cardiovascular procedures.
Questions
AI-generated answers, 19 Sep 2026
What is the primary clinical purpose of the True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, and how does it function during a procedure?
The True Dilatation Percutaneous Transluminal Valvuloplasty Catheter is designed specifically for balloon aortic valvuloplasty, a percutaneous intervention to dilate stenotic (narrowed) aortic valves. During use, it is advanced over a guidewire to the target valve site, then inflated with radiopaque contrast media via a syringe to mechanically widen the narrowed valve and improve blood flow.
Is this catheter intended for single-use or repeated use, and what sterilization requirements apply?
This catheter is supplied as a single-use device and is non-sterile at the time of packaging. It must be sterilized prior to use, as it is not pre-sterilized by the manufacturer. Follow established hospital sterilization protocols to ensure safety before deployment.
What are the key dimensions of the catheter, and how does its design support its intended use?
The catheter measures 20mm in diameter and 4.5cm in length, with a fixed balloon at the tip. These dimensions are optimized for aortic valvuloplasty, allowing precise dilation of stenotic aortic valves while maintaining compatibility with standard guidewire systems and radiographic visualization due to its radiopaque construction.
How is the catheter positioned and inflated during a procedure, and what equipment is required?
The catheter is positioned over a guidewire and advanced to the target valve site under fluoroscopic guidance. Inflation is achieved via a syringe inflation device, delivering radiopaque contrast media to the balloon. This ensures both mechanical dilation of the valve and real-time radiographic confirmation of placement and expansion.
What regulatory pathway does this device follow, and which advisory committee oversees its classification?
This device holds an FDA 510K clearance under the Traditional Review pathway and is classified as Class II under product code OZT. It is regulated under 21 CFR 870.1255 and falls under the purview of the Cardiovascular (CV) Advisory Committee, reflecting its use in cardiovascular procedures.