Oracle Micro PTCA Catheter Fact Balloon Coronary Dilation Catheter
PMA P910031
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP910031 | Date30 Sep 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Cathscanner Oracle Micro Ptca Catheter Fact Balloon Coronary Dilation Catheter
- Trade Name
- Oracle(Tm) Coronary Balloon Dilatation Catheter
- Generic Name
- Catheters, transluminal coronary angioplasty, percutaneous
- PMA Number
- FDA Product Code
- LOX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5100
- Advisory Committee
- Cardiovascular
- FDA Decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
This device is a Catheter, Transluminal Coronary Angioplasty, Percutaneous, designed for coronary artery dilation. It is a balloon catheter used in percutaneous transluminal coronary angioplasty (PTCA) to mechanically widen narrowed or obstructed coronary arteries, improving blood flow to the heart muscle.
The Oracle Micro PTCA Catheter Fact Balloon is supplied as a single-use, non-sterile device for professional medical use. It is regulated under the FDA_PMA authorization (PMA Number: P910031) and falls under Device Class II (Regulation Number: 870.5100). The catheter is intended for use in controlled clinical settings, such as cardiac catheterization labs, and requires proper handling and storage as specified by the manufacturer.
Other devices from Abbott Vascular Devices
Questions
AI-generated answers, 18 Sep 2026
What is the primary clinical purpose of the Oracle Micro PTCA Catheter Fact Balloon, and where is it typically used?
The Oracle Micro PTCA Catheter Fact Balloon is designed specifically for coronary artery dilation during percutaneous transluminal coronary angioplasty (PTCA). It mechanically widens narrowed or obstructed coronary arteries to restore blood flow to the heart muscle. This procedure is performed in controlled clinical settings, such as cardiac catheterization labs, where specialized equipment and trained personnel are available to monitor and manage the intervention.
Is this device intended for single-use or repeated use, and what does that mean for my workflow?
The Oracle Micro PTCA Catheter Fact Balloon is single-use only, meaning it is not designed for reuse after a single procedure. This ensures patient safety by preventing contamination or degradation of the device, which could compromise its performance or introduce infection risks. After use, the catheter must be discarded according to medical waste protocols, and a new, sterile device must be prepared for subsequent procedures.
How is the Oracle Micro PTCA Catheter Fact Balloon supplied, and does it come pre-sterilized?
The device is supplied as non-sterile, meaning it requires terminal sterilization by the healthcare facility before use. This process typically involves steam autoclaving or ethylene oxide treatment, depending on facility protocols. The catheter must be handled and stored in accordance with the manufacturer’s instructions to maintain its integrity until sterilization is completed.
What regulatory pathway does this device follow, and how does that affect its availability or use?
The Oracle Micro PTCA Catheter Fact Balloon is regulated under the FDA’s Premarket Approval (PMA) pathway, with the approval number P910031. This classification (Device Class II) indicates that the FDA has determined the device poses moderate risk and requires rigorous pre-market evaluation to ensure safety and effectiveness. While this does not directly impact daily clinical use, it confirms the device meets stringent regulatory standards for coronary dilation procedures.