Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
April 14, 2023
April 13, 2023
32b5da37-c588-499e-b185-8836c149827f
Related Documents
Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentAugust 22, 2025Center for Devices and Radiological Health
Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentDecember 23, 2021Center for Devices and Radiological Health
Bone Anchors - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentMarch 3, 2020Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox