Catheter, Ventricular, General & Plastic Surgery
FDA product code GBS · Class I (low risk) · 21 CFR 878.4200 · General, Plastic Surgery
27510(k) clearances
0PMA approvals
20recalls
Manufacturers
- Axiom Medical, Inc. 3
- H.W. Andersen Products, Inc. 3
- C.R. Bard, Inc. 2
- Sil-Med Corp. 2
- Sherwood Medical Co. 2
- Sheridan Catheter Corp. 2
- Uresil Corp. 2
- Treace Medical, Inc. 1
- Atrium Medical Corporation 1
- Axiom, Inc. 1
- Genesis Industries, Inc. 1
- Gish Biomedical, Inc. 1
- Health Care Innovations, Inc. 1
- J. H. Emerson Co. 1
- Medovations, Inc. 1
- Snyder Laboratories, Inc. 1
- Texas Medical Products, Inc. 1
- Medspec Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K912645 | Atriums PDR Thoracic CatheterGBS · Traditional | Atrium Medical Corp. | 09/13/1991SE |
| K883887 | Axiom Atraum Wound DrainsGBS · Traditional | Axiom, Inc. | 02/17/1989SE |
| K881873 | Introduction/Drainage Catheter & AccessGBS · Traditional | Sheridan Catheter Corp. | 05/18/1988SE |
| K880895 | Uresil Wound Drain TrocarGBS · Traditional | Uresil Corp. | 03/14/1988SE |
| K880376 | Novo Vivo Suction Catheter Vessel W/Mucose TrapGBS · Traditional | Genesis Industries, Inc. | 02/16/1988SE |
| K873377 | Closed Chest Drainage Set W/SuturesGBS · Traditional | Gish Biomedical, Inc. | 10/28/1987SE |
| K872460 | AN3000 Mahoney DrainGBS · Traditional | H.W. Andersen Products, Inc. | 07/23/1987SE |
| K872459 | AN3100 Mulholland DrainGBS · Traditional | H.W. Andersen Products, Inc. | 07/21/1987SE |
| K872457 | AN3500 Worth DrainGBS · Traditional | H.W. Andersen Products, Inc. | 07/21/1987SE |
| K870015 | Hci All Purpose Drain/Catheter SetGBS · Traditional | Health Care Innovations, Inc. | 02/06/1987SE |
| K863560 | Uresil STD Flat/Round & Flat/Round Split. Sili/DraGBS · Traditional | Uresil Corp. | 09/29/1986SE |
| K863247 | Axiom Trocar Thoracic CatheterGBS · Traditional | Axiom Medical, Inc. | 08/29/1986SE |
| K863142 | Thoracic Catheter (Chest Drainage Tube)GBS · Traditional | Sheridan Catheter Corp. | 08/29/1986SE |
| K862584 | Osteotomy Drainage TubeGBS · Traditional | Treace Medical, Inc. | 08/12/1986SE |
| K862767 | Silicone Sump DrainGBS · Traditional | Sil-Med Corp. | 08/07/1986SE |
| K854418 | Round Suction DrainGBS · Traditional | Sil-Med Corp. | 11/19/1985SE |
| K853131 | Thoro/Cath Straight Thoracic Right AngleGBS · Traditional | J. H. Emerson Co. | 09/05/1985SE |
| K852241 | Axiom Atraum Trocar CatheterGBS · Traditional | Axiom Medical, Inc. | 06/14/1985SE |
| K851048 | Chest Catheters/Thoracic CathetersGBS · Traditional | Medovations, Inc. | 06/05/1985SE |
| K843906 | Snyder Hemovac Wound Drainage DevicesGBS · Traditional | Snyder Laboratories, Inc. | 11/05/1984SE |
| K832416 | Axiom Hydromer Wound DrainsGBS · Traditional | Axiom Medical, Inc. | 10/31/1983SE |
| K822318 | Argyle Mediastinal DrainGBS · Traditional | Sherwood Medical Co. | 08/27/1982SE |
| K813463 | Sil-V-Ur Chest CatheterGBS · Traditional | C.R. Bard, Inc. | 02/12/1982SE |
| K813587 | Disposable Thoracic CatheterGBS · Traditional | Texas Medical Products, Inc. | 01/12/1982SE |
| K810158 | Davol Silicone Sheath Sump DrainGBS · Traditional | C.R. Bard, Inc. | 02/13/1981SE |
| K810071 | Sterile Silicone TubingGBS · Traditional | Medspec Corp. | 02/12/1981SE |
| K802318 | Argyle Silicone Thoracic CatheterGBS · Traditional | Sherwood Medical Co. | 10/23/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0020-2011 | HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132Mislabeled: One lot of 32Fr Straight Catheters packaged and labeled as 24Fr Straight Catheters. | Atrium Medical Corporation | 08/10/2010Terminated |
| Z-0019-2011 | HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124Mislabeled: One lot of 24Fr Straight Catheters packaged and labeled as 32Fr Straight Catheters. | Atrium Medical Corporation | 08/10/2010Terminated |
| Z-0899-2011 | Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF…Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing. | Concentric Medical Inc | 02/27/2009Terminated |
| Z-1846-2008 | ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9428, Size (Fr) 28, #…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1845-2008 | ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9420, Size (Fr) 20, #…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1844-2008 | ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9408, Size (Fr) 8, #…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1843-2008 | HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1842-2008 | HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1841-2008 | HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1840-2008 | HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1839-2008 | HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1838-2008 | HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparinc allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1837-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1836-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1835-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1834-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1833-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1832-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1831-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1830-2008 | HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |