GCC · Dilator, Catheter
General, Plastic Surgery · 21 CFR 878.4200 · Class 1
Overview
| Product Code | GCC |
|---|---|
| Device Name | Dilator, Catheter |
| Regulation | 21 CFR 878.4200 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K981061 | INTRAVASCULAR RETRIEVAL DEVICE | Med Institute, Inc. | May 26, 1998 | SESE |
| K922354 | BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET | Med Institute, Inc. | Jul 30, 1992 | SESE |
| K902502 | BYRD STAINLESS STEEL DILATOR | Medical Engineering and Development Institute | Aug 7, 1990 | SESE |
| K893480 | BYRD EXTRACTOR SET | Medical Engineering and Development Institute | Jun 23, 1989 | SESE |
| K820865 | VAN-TEC FASCIAL DILATOR | Van-Tec, Inc. | May 5, 1982 | SESE |
Top Applicants
- Medical Engineering and Development Institute — 2 clearances
- Med Institute, Inc. — 2 clearances
- Van-Tec, Inc. — 1 clearance
