GBX · Catheter, Irrigation
General, Plastic Surgery · 21 CFR 878.4200 · Class 1
Overview
| Product Code | GBX |
|---|---|
| Device Name | Catheter, Irrigation |
| 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 (20 of 77)
Showing 20 most recent of 77 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K131659 | MOERAE VEIN PREPARATION KIT | Moerae Matrix, Inc. | Mar 3, 2014 | SESE |
| K082725 | GRAFTGUARD PRESSURE CONTROLLING SYRINGE | Maquet Cardiovascular, LLC | Dec 17, 2008 | SESE |
| K052286 | DEUTSCH ANTI-BLOCKAGE WOUND DRAIN | The Catheter Exchange, Inc. | Oct 21, 2005 | SESE |
| K043515 | GRAFTSAVER | Vescare, Inc. | Mar 31, 2005 | SESE |
| K013417 | MISONIX IRRIGATION SYSTEM MOEDL BC20P | Misonix, Inc. | Jan 10, 2002 | SESE |
| K000704 | DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) | Dmc Medical, Ltd. | May 19, 2000 | SESE |
| K974233 | LYSONIX IRRIGATION SYSTEM | Lysonix, Inc. | Feb 3, 1998 | SESE |
| K973703 | JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN | Allegiance Healthcare Corp. | Dec 4, 1997 | SESE |
| K972635 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | Oct 1, 1997 | SESE |
| K965146 | FLAT CLOSED WOUND DRAIN WITH TROCAR | Axiom Medical, Inc. | Mar 10, 1997 | SESE |
| K961295 | SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR | Sil-Med Corp. | Jun 26, 1996 | SESE |
| K961147 | CLOSED FLUID COLLECTION SYSTEM | B.Braun Medical, Inc. | May 31, 1996 | SESE |
| K960955 | JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING | Baxter Healthcare Corp | May 22, 1996 | SESE |
| K955339 | HYDROLOGY 5000 | Northgate Technologies, Inc. | Mar 13, 1996 | SESE |
| K955474 | NEO-PNEUMOCATH | Intra Special Catheters GmbH | Feb 13, 1996 | SESE |
| K955505 | OPTI-DRAIN MULTI-USE DRAINAGE CATHETER | Navarre Biomedical , Ltd. | Feb 7, 1996 | SESE |
| K955439 | THE REEL THING (MODIFICATION) | Biomedical Devices, Inc. | Dec 26, 1995 | SESE |
| K926496 | SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN | Sil-Med Corp. | May 24, 1995 | SESE |
| K951907 | NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER | Navarre Biomedical , Ltd. | May 15, 1995 | SESE |
| K951475 | NAVARRE UNIVERSAL DRAINAGE CATHETER | Navarre Biomedical , Ltd. | Apr 24, 1995 | SESE |
Top Applicants
- Navarre Biomedical , Ltd. — 5 clearances
- Sil-Med Corp. — 5 clearances
- Axiom Medical, Inc. — 3 clearances
- Kendall Healthcare Products Co. Div.Of Tyco Health — 3 clearances
- Mikro-Tek Laboratories — 3 clearances
