U.S. FDA Medical Device Infusion Catheter Requirements
FDA Medical Device Definition: An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.
FDA Infusion Catheter Label Requirements and Exceptions
FDA Infusion Catheter Import Information
FDA Infusion Catheter Detentions (Infusion Catheter Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Infusion Catheter Manufacturers (Infusion Catheter Suppliers)
- Infusion Catheter Distributors
- Infusion Catheter Processors
- Infusion Catheter Repackers
- Infusion Catheter Relabelers
- Infusion Catheter Exporters
- Infusion Catheter Importers
For more information about Infusion Catheter Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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