Dilator, Catheter
FDA product code GCC · Class I (low risk) · 21 CFR 878.4200 · General, Plastic Surgery
5510(k) clearances
0PMA approvals
5recalls
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K981061 | Intravascular Retrieval DeviceGCC · Traditional | Med Institute, Inc. | 05/26/1998SE |
| K922354 | Byrd Telescoping Stainless Steel Dilat Sheath SetGCC · Traditional | Med Institute, Inc. | 07/30/1992SE |
| K902502 | Byrd Stainless Steel DilatorGCC · Traditional | Medical Engineering and Development Institute | 08/07/1990SE |
| K893480 | Byrd Extractor SetGCC · Traditional | Medical Engineering and Development Institute | 06/23/1989SE |
| K820865 | Van-Tec Fascial DilatorGCC · Traditional | Van-Tec, Inc. | 05/05/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0097-2014 Class II | PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are…Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not… | DePuy Spine, Inc. | 07/31/2013Terminated |
| Z-0096-2014 Class II | PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and…Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not… | DePuy Spine, Inc. | 07/31/2013Terminated |
| Z-0095-2014 Class II | PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and…Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not… | DePuy Spine, Inc. | 07/31/2013Terminated |
| Z-0094-2014 Class II | PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and…Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not… | DePuy Spine, Inc. | 07/31/2013Terminated |
| Z-0093-2014 Class II | PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and…Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not… | DePuy Spine, Inc. | 07/31/2013Terminated |