Catheter, Ventricular, General & Plastic Surgery
The Catheter, Ventricular, General and Plastic Surgery (product code GBS) is a catheter placed within a ventricle of the brain or heart to drain cerebrospinal fluid or monitor pressure, used in neurological or cardiac surgical contexts within the general and plastic surgery category. It is classified as FDA Class 1, the lowest risk level, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4200 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
Basic Information
- Product Code
- GBS
- Device Class
- FDA class 1
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 27 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K912645 | ATRIUMS PDR THORACIC CATHETER | Sep 13, 1991 | Substantially Equivalent | ATRIUM MEDICAL CORP. |
| K883887 | AXIOM ATRAUM WOUND DRAINS | Feb 17, 1989 | Substantially Equivalent | AXIOM, INC. |
| K881873 | INTRODUCTION/DRAINAGE CATHETER & ACCESS | May 18, 1988 | Substantially Equivalent | SHERIDAN CATHETER CORP. |
| K880895 | URESIL WOUND DRAIN TROCAR | Mar 14, 1988 | Substantially Equivalent | URESIL CORP. |
| K880376 | NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP | Feb 16, 1988 | Substantially Equivalent | GENESIS INDUSTRIES, INC. |
| K873377 | CLOSED CHEST DRAINAGE SET W/SUTURES | Oct 28, 1987 | Substantially Equivalent | GISH BIOMEDICAL, INC. |
| K872460 | AN3000 MAHONEY DRAIN | Jul 23, 1987 | Substantially Equivalent | H.W. ANDERSEN PRODUCTS, INC. |
| K872459 | AN3100 MULHOLLAND DRAIN | Jul 21, 1987 | Substantially Equivalent | H.W. ANDERSEN PRODUCTS, INC. |
| K872457 | AN3500 WORTH DRAIN | Jul 21, 1987 | Substantially Equivalent | H.W. ANDERSEN PRODUCTS, INC. |
| K870015 | HCI ALL PURPOSE DRAIN/CATHETER SET | Feb 06, 1987 | Substantially Equivalent | HEALTH CARE INNOVATIONS, INC. |
| K863560 | URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA | Sep 29, 1986 | Substantially Equivalent | URESIL CORP. |
| K863247 | AXIOM TROCAR THORACIC CATHETER | Aug 29, 1986 | Substantially Equivalent | AXIOM MEDICAL, INC. |
| K863142 | THORACIC CATHETER (CHEST DRAINAGE TUBE) | Aug 29, 1986 | Substantially Equivalent | SHERIDAN CATHETER CORP. |
| K862584 | OSTEOTOMY DRAINAGE TUBE | Aug 12, 1986 | Substantially Equivalent | TREACE MEDICAL, INC. |
| K862767 | SILICONE SUMP DRAIN | Aug 07, 1986 | Substantially Equivalent | SIL-MED CORP. |
| K854418 | ROUND SUCTION DRAIN | Nov 19, 1985 | Substantially Equivalent | SIL-MED CORP. |
| K853131 | THORO/CATH STRAIGHT THORACIC RIGHT ANGLE | Sep 05, 1985 | Substantially Equivalent | J. H. EMERSON CO. |
| K852241 | AXIOM ATRAUM TROCAR CATHETER | Jun 14, 1985 | Substantially Equivalent | AXIOM MEDICAL, INC. |
| K851048 | CHEST CATHETERS/THORACIC CATHETERS | Jun 05, 1985 | Substantially Equivalent | MEDOVATIONS, INC. |
| K843906 | SNYDER HEMOVAC WOUND DRAINAGE DEVICES | Nov 05, 1984 | Substantially Equivalent | SNYDER LABORATORIES, INC. |
| K832416 | AXIOM HYDROMER WOUND DRAINS | Oct 31, 1983 | Substantially Equivalent | AXIOM MEDICAL, INC. |
| K822318 | ARGYLE MEDIASTINAL DRAIN | Aug 27, 1982 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K813463 | SIL-V-UR CHEST CATHETER | Feb 12, 1982 | Substantially Equivalent | C.R. BARD, INC. |
| K813587 | DISPOSABLE THORACIC CATHETER | Jan 12, 1982 | Substantially Equivalent | TEXAS MEDICAL PRODUCTS, INC. |
| K810158 | DAVOL SILICONE SHEATH SUMP DRAIN | Feb 13, 1981 | Substantially Equivalent | C.R. BARD, INC. |
| K810071 | STERILE SILICONE TUBING | Feb 12, 1981 | Substantially Equivalent | MEDSPEC CORP. |
| K802318 | ARGYLE SILICONE THORACIC CATHETER | Oct 23, 1980 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
FEI Numbers
This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.