GBA · Catheter, Balloon Type
General, Plastic Surgery · 21 CFR 878.4200 · Class 1
Overview
| Product Code | GBA |
|---|---|
| Device Name | Catheter, Balloon Type |
| 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.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K861877 | BYRON WORD BARTHOLIAN GLAND CATHETER | Byron Medical | May 30, 1986 | SESE |
| K802025 | BALLOON RETENTION CHEST CATHETER | Loseff Medical Designers, Ltd. | Sep 26, 1980 | SESE |
| K790444 | ELECATH MULTI-PURPOSE ARTERIAL SURGER | Electro-Catheter Corp. | Jun 11, 1979 | SESE |
| K781772 | CATHETER, TRANSLUMINAL BALLOON | Medi-Tech, Inc. | Mar 6, 1979 | SESE |
| K781665 | TUBE, LEATHERMAN/IMBRUCE | National Catheter Co. Div. Mallinckrodt | Dec 15, 1978 | SESE |
Top Applicants
- National Catheter Co. Div. Mallinckrodt — 1 clearance
- Medi-Tech, Inc. — 1 clearance
- Loseff Medical Designers, Ltd. — 1 clearance
- Electro-Catheter Corp. — 1 clearance
- Byron Medical — 1 clearance
