MICROFLOW IRRIGATION SYSTEM
Device Facts
| Record ID | K941356 |
|---|---|
| Device Name | MICROFLOW IRRIGATION SYSTEM |
| Applicant | Jedmed Instrument Co. |
| Product Code | GBQ · General, Plastic Surgery |
| Decision Date | May 19, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4200 |
| Device Class | Class 1 |
Regulatory Classification
Identification
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.
