Product code FEW
- Device name
- Catheter, Malecot
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5090
- Review panel
- GU
- 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 |
|---|---|---|---|
| K140085 | UNIVERSA PERCULTANEOUS DRAINAGE CATHETER | Cook Incorporated | 2014-11-18 |
| K070879 | BARD MALECOT AND PEZZER DRAINS | C.R. Bard, Inc. | 2007-04-24 |
| K981258 | MANAN MALECOT BASKET DRAINAGE CATHETER | Medical Device Technologies, Inc. | 1998-04-22 |
| K954147 | MANAN MALECOT BASKET DRAINAGE CATHETER | Manan Medical Products, Inc. | 1996-03-26 |
| K954116 | SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP | Technical Products, Inc. | 1995-11-06 |
| K920423 | OLYMPIC SMART SCALE CARE CENTER | Olympic Medical Corp. | 1992-06-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00801741023965 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741030086 | Bardex® Pezzer Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741030079 | Bardex® Pezzer Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741030062 | Bardex® Pezzer Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741030055 | Bardex® Pezzer Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741030048 | Bardex® Pezzer Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741030031 | Bardex® Pezzer Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741030024 | Bardex® Pezzer Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741030017 | Bardex® Pezzer Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741023811 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741023958 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741023941 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741023927 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741023828 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741023835 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741023842 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741023859 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741023866 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741023873 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741023880 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741023897 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741023903 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741023910 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741023934 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-06-10 |
| 00801741024023 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-05-31 |
| 00801741024016 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-05-31 |
| 00801741024009 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-05-31 |
| 00801741023996 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-05-31 |
| 00801741023989 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-05-31 |
| 00801741023972 | Bardex® Malecot Model Drain | C. R. Bard, Inc. | 2016-05-31 |