GBS · Catheter, Ventricular, General & Plastic Surgery
General, Plastic Surgery · 21 CFR 878.4200 · Class 1
Overview
| Product Code | GBS |
|---|---|
| Device Name | Catheter, Ventricular, General & Plastic Surgery |
| 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 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K912645 | ATRIUMS PDR THORACIC CATHETER | Atrium Medical Corp. | Sep 13, 1991 | SESE |
| K883887 | AXIOM ATRAUM WOUND DRAINS | Axiom, Inc. | Feb 17, 1989 | SESE |
| K881873 | INTRODUCTION/DRAINAGE CATHETER & ACCESS | Sheridan Catheter Corp. | May 18, 1988 | SESE |
| K880895 | URESIL WOUND DRAIN TROCAR | Uresil Corp. | Mar 14, 1988 | SESE |
| K880376 | NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP | Genesis Industries, Inc. | Feb 16, 1988 | SESE |
| K873377 | CLOSED CHEST DRAINAGE SET W/SUTURES | Gish Biomedical, Inc. | Oct 28, 1987 | SESE |
| K872460 | AN3000 MAHONEY DRAIN | H.W. Andersen Products, Inc. | Jul 23, 1987 | SESE |
| K872459 | AN3100 MULHOLLAND DRAIN | H.W. Andersen Products, Inc. | Jul 21, 1987 | SESE |
| K872457 | AN3500 WORTH DRAIN | H.W. Andersen Products, Inc. | Jul 21, 1987 | SESE |
| K870015 | HCI ALL PURPOSE DRAIN/CATHETER SET | Health Care Innovations, Inc. | Feb 6, 1987 | SESE |
| K863560 | URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA | Uresil Corp. | Sep 29, 1986 | SESE |
| K863247 | AXIOM TROCAR THORACIC CATHETER | Axiom Medical, Inc. | Aug 29, 1986 | SESE |
| K863142 | THORACIC CATHETER (CHEST DRAINAGE TUBE) | Sheridan Catheter Corp. | Aug 29, 1986 | SESE |
| K862584 | OSTEOTOMY DRAINAGE TUBE | Treace Medical, Inc. | Aug 12, 1986 | SESE |
| K862767 | SILICONE SUMP DRAIN | Sil-Med Corp. | Aug 7, 1986 | SESE |
| K854418 | ROUND SUCTION DRAIN | Sil-Med Corp. | Nov 19, 1985 | SESE |
| K853131 | THORO/CATH STRAIGHT THORACIC RIGHT ANGLE | J. H. Emerson Co. | Sep 5, 1985 | SESE |
| K852241 | AXIOM ATRAUM TROCAR CATHETER | Axiom Medical, Inc. | Jun 14, 1985 | SESE |
| K851048 | CHEST CATHETERS/THORACIC CATHETERS | Medovations, Inc. | Jun 5, 1985 | SESE |
| K843906 | SNYDER HEMOVAC WOUND DRAINAGE DEVICES | Snyder Laboratories, Inc. | Nov 5, 1984 | SESE |
Top Applicants
- Axiom Medical, Inc. — 3 clearances
- H.W. Andersen Products, Inc. — 3 clearances
- C.R. Bard, Inc. — 2 clearances
- Sheridan Catheter Corp. — 2 clearances
- Sherwood Medical Co. — 2 clearances
