Download Atherectomy Devices - FDA PreMarket Notification 510k Submission Draft Guidance PDF Free - Full Version
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About Atherectomy Devices - FDA PreMarket Notification 510k Submission Draft Guidance
This draft guidance provides recommendations for 510(k) submissions for peripheral vascular atherectomy devices. It covers topics such as device description, predicate device comparison, software, biocompatibility, sterility, electrical safety, battery testing, non-clinical bench testing, animal testing, clinical performance testing, and labeling. The guidance is intended to assist industry in preparing 510(k) submissions for these devices.
Detailed Information
| Author: | ['hamartinez'] |
|---|---|
| Publication Year: | 2020 |
| Pages: | 31 |
| Language: | English |
| Format: | |
| Price: | FREE |
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