U.S. FDA Medical Device Catheter Adaptor 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 Catheter Adaptor Label Requirements and Exceptions
FDA Catheter Adaptor Import Information
FDA Catheter Adaptor Detentions (Catheter Adaptor Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Catheter Adaptor Manufacturers (Catheter Adaptor Suppliers)
- Catheter Adaptor Distributors
- Catheter Adaptor Processors
- Catheter Adaptor Repackers
- Catheter Adaptor Relabelers
- Catheter Adaptor Exporters
- Catheter Adaptor Importers
For more information about Catheter Adaptor 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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