Product code MAD
- Device name
- Catheter, Percutaneous (Valvuloplasty)
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P910054S010 | INOUE BALLOON CATHETER | Toray Industries (America), Inc. | 2024-07-01 |
| P910054S009 | Inoue-Balloon Catheter | Toray Industries (America), Inc. | 2024-05-24 |
| P910054S008 | INOUE-BALLOON Catheter | Toray Industries (America), Inc. | 2021-08-31 |
| P910054S007 | Inoue Balloon Catheter | Toray Industries (America), Inc. | 2020-03-30 |
| P910054S006 | Toray Inoue Balloon Catheter | Toray Industries (America), Inc. | 2018-09-13 |
| P910054S005 | TORAY INOUE BALLOON CATHETER | Toray Industries (America), Inc. | 2011-05-17 |
| P910054S004 | TORAY INOUE BALLON CATHETER | Toray Industries (America), Inc. | 2007-07-03 |
| P910054S002 | INOUE BALLOON CATHETER | Toray Industries (America), Inc. | 2002-02-13 |
| P910054S001 | INOUE BALLOON CATHETER | Toray Industries (America), Inc. | 1995-11-30 |
| P910054 | INOUE BALLOON CATHETER | Toray Industries (America), Inc. | 1994-06-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04046964334122 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334405 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334375 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334368 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334344 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334320 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334306 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334283 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334269 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334245 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334221 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334207 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334184 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334160 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334153 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964333835 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334108 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334085 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334078 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334047 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334023 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964334016 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964333996 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964333965 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964333941 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964333934 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964333903 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964333880 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964333873 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964333859 | COEfficient™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |