Product code GBS
- Device name
- Catheter, Ventricular, General & Plastic Surgery
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4200
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K912645 | ATRIUMS PDR THORACIC CATHETER | Atrium Medical Corp. | 1991-09-13 |
| K883887 | AXIOM ATRAUM WOUND DRAINS | Axiom, Inc. | 1989-02-17 |
| K881873 | INTRODUCTION/DRAINAGE CATHETER & ACCESS | Sheridan Catheter Corp. | 1988-05-18 |
| K880895 | URESIL WOUND DRAIN TROCAR | Uresil Corp. | 1988-03-14 |
| K880376 | NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP | Genesis Industries, Inc. | 1988-02-16 |
| K873377 | CLOSED CHEST DRAINAGE SET W/SUTURES | Gish Biomedical, Inc. | 1987-10-28 |
| K872460 | AN3000 MAHONEY DRAIN | H.W. Andersen Products, Inc. | 1987-07-23 |
| K872459 | AN3100 MULHOLLAND DRAIN | H.W. Andersen Products, Inc. | 1987-07-21 |
| K872457 | AN3500 WORTH DRAIN | H.W. Andersen Products, Inc. | 1987-07-21 |
| K870015 | HCI ALL PURPOSE DRAIN/CATHETER SET | Health Care Innovations, Inc. | 1987-02-06 |
| K863560 | URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA | Uresil Corp. | 1986-09-29 |
| K863247 | AXIOM TROCAR THORACIC CATHETER | Axiom Medical, Inc. | 1986-08-29 |
| K863142 | THORACIC CATHETER (CHEST DRAINAGE TUBE) | Sheridan Catheter Corp. | 1986-08-29 |
| K862584 | OSTEOTOMY DRAINAGE TUBE | Treace Medical, Inc. | 1986-08-12 |
| K862767 | SILICONE SUMP DRAIN | Sil-Med Corp. | 1986-08-07 |
| K854418 | ROUND SUCTION DRAIN | Sil-Med Corp. | 1985-11-19 |
| K853131 | THORO/CATH STRAIGHT THORACIC RIGHT ANGLE | J. H. Emerson Co. | 1985-09-05 |
| K852241 | AXIOM ATRAUM TROCAR CATHETER | Axiom Medical, Inc. | 1985-06-14 |
| K851048 | CHEST CATHETERS/THORACIC CATHETERS | Medovations, Inc. | 1985-06-05 |
| K843906 | SNYDER HEMOVAC WOUND DRAINAGE DEVICES | Snyder Laboratories, Inc. | 1984-11-05 |
| K832416 | AXIOM HYDROMER WOUND DRAINS | Axiom Medical, Inc. | 1983-10-31 |
| K822318 | ARGYLE MEDIASTINAL DRAIN | Sherwood Medical Co. | 1982-08-27 |
| K813463 | SIL-V-UR CHEST CATHETER | C.R. Bard, Inc. | 1982-02-12 |
| K813587 | DISPOSABLE THORACIC CATHETER | Texas Medical Products, Inc. | 1982-01-12 |
| K810158 | DAVOL SILICONE SHEATH SUMP DRAIN | C.R. Bard, Inc. | 1981-02-13 |
| K810071 | STERILE SILICONE TUBING | Medspec Corp. | 1981-02-12 |
| K802318 | ARGYLE SILICONE THORACIC CATHETER | Sherwood Medical Co. | 1980-10-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M665100032ATX0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2020-11-13 |
| M665100028ATX0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2020-11-13 |
| M665100020AT0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100036AT0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100032ATSC0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100032ATS0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100032AT0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100028ATSC0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100028ATS0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100028AT0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100024ATSC0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100024ATS0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100024AT0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100020ATSC0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100020ATS0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100008AT0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100016ATSC0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100016ATS0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100016AT0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100014ATSC0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100014ATS0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100014AT0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100012ATSC0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100012ATS0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100012AT0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100010ATSC0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100010ATS0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100010AT0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100008ATSC0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |
| M665100008ATS0 | Axiom® Atraum™ With ClotStop® | AXIOM MEDICAL, INCORPORATED | 2018-09-23 |