Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling
Posts tagged as “Guidance”
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations
9/13/2019 – Format for Traditional and Abbreviated 510(k)s: Guidance for Industry and FDA Staff 9/13/2019 – Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food…
Acceptance Review for De Novo Classification Requests
Humanitarian Device Exemption (HDE) Program
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers