Cardiovascular 14
- Testing Considerations for Percutaneous Transluminal Angioplasty (PTA) and Specialty Balloon Catheters
- Peripheral Vascular Atherectomy Devices - Content and Testing Requirements for 510k Submissions
- Labeling for Intravascular Devices with Lubricious Coatings
- Coronary, Peripheral, and Neurovascular Guidewires - Performance Testing and Documentation Requirements
- 510k Exemption for Unclassified Medical Devices in Selected Product Categories
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- Design Considerations and Recommendations for Interoperable Medical Devices
- Procedures for Medical Devices Advisory Committee Panel Meetings
- Use of Real-World Data to Generate Evidence for Medical Device Regulatory Decisions
- Assessment of Radiofrequency-Induced Heating in Multi-Configuration Passive Medical Devices for MR Conditional Labeling
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- C-Reactive Protein (CRP) Assays - Premarket Notification 510k Submissions
- Inferior Vena Cava Filters - Testing and Labeling Requirements
- Premarket Notification Requirements for Cardiac Monitors, Heart Rate Meters, and Alarms