Product code DQT
- Device name
- Occluder, Catheter Tip
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1370
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K983927 | GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT | Arterial Vascular Engineering, Inc. | 1999-03-11 |
| K945963 | THE OMNIGUIDE GUIDING CATHETER WITH BALLOON | Micro Interventional Systems, Inc. | 1995-02-08 |
| K910916 | CATHLAB SILICONE OCCLUSION BALLOON CATHETER | Cathlab Corp. | 1991-06-24 |
| K910339 | AVD INTIMAX OCCLUSION CATHETER | Applied Vascular Devices, Inc. | 1991-05-29 |
| K880860 | CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 | Dlp, Inc. | 1988-05-26 |
| K880231 | MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER | Ideas For Medicine, Inc. | 1988-05-25 |
| K872090 | THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT | Ideas For Medicine, Inc. | 1987-10-30 |
| K872790 | PERFUSION CATHETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-09-15 |
| K872154 | MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH | Ideas For Medicine, Inc. | 1987-08-03 |
| K863559 | URESIL OCCLUSION BALLOON CATHETER | Uresil Corp. | 1986-10-10 |
| K844918 | OCCLUSION & OCCLUSION-IRRIGATION | Clincal Instruments Corp. | 1985-08-05 |
| K840795 | ACS SOF-T GUIDE WIREE | Advanced Cardiovascular Systems, Inc. | 1984-07-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840663101511 | Pruitt Aortic Occlusion Catheter | Lemaitre Vascular, Inc. | 2015-06-30 |
| 00840663101528 | Pruitt Aortic Occlusion Catheter | Lemaitre Vascular, Inc. | 2015-06-30 |
| 00840663101535 | Pruitt Irrigation Occlusion Catheter | Lemaitre Vascular, Inc. | 2015-06-30 |
| 00840663101542 | Pruitt Irrigation Occlusion Catheter | Lemaitre Vascular, Inc. | 2015-06-30 |
| 00840663102259 | Polyurethane Dual Lumen Occlusion Catheter | Lemaitre Vascular, Inc. | 2015-06-30 |
| 00840663102266 | Polyurethane Dual Lumen Occlusion Catheter | Lemaitre Vascular, Inc. | 2015-06-30 |
| 00840663102273 | Polyurethane Dual Lumen Occlusion Catheter | Lemaitre Vascular, Inc. | 2015-06-30 |
| 00840663102280 | Polyurethane Dual Lumen Occlusion Catheter | Lemaitre Vascular, Inc. | 2015-06-30 |