Z-MED™
PDZ371 Special Z-MED 11X3X100
1manufacturer
60catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | B. Braun Interventional Systems, Inc., United States |
|---|---|
| FDA product code | OZT |
| Device type | Balloon Aortic Valvuloplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1255 |
| 510(k) | K122012 |
| Record published | 2016-08-09 |
| Record revised | 2023-09-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at room temp; Special storage condition: Keep away from sunlight |
| Distribution end date | 2021-08-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 610488 | In distribution | |
| 611801 | In distribution | |
| 610448 | In distribution | |
| 610638 | In distribution | |
| 611476 | In distribution | |
| 611686 | In distribution | |
| 611821 | In distribution | |
| 610484 | In distribution | |
| 610445 | In distribution | |
| 610492 | In distribution | |
| 610469 | In distribution | |
| 610461 | In distribution | |
| 610487 | In distribution | |
| 610496 | In distribution | |
| 610444 | In distribution | |
| 610463 | In distribution | |
| 611673 | In distribution | |
| 610468 | In distribution | |
| 611811 | In distribution | |
| 611670 | In distribution | |
| 610442 | In distribution | |
| 610480 | In distribution | |
| 610470 | In distribution | |
| 610485 | In distribution | |
| 611479 | In distribution | |
| 610481 | In distribution | |
| 611684 | In distribution | |
| 610456 | In distribution | |
| 610497 | In distribution | |
| 611651 | In distribution | |
| 610234 | In distribution | |
| 611671 | In distribution | |
| 610483 | In distribution | |
| 611679 | In distribution | |
| 611685 | In distribution | |
| 610462 | In distribution | |
| 611682 | In distribution | |
| 611822 | In distribution | |
| 610472 | In distribution | |
| 610465 | In distribution | |
| 611824 | In distribution | |
| 610242 | In distribution | |
| 610441 | In distribution | |
| 610489 | In distribution | |
| 610238 | In distribution | |
| 611810 | In distribution | |
| 611680 | In distribution | |
| 610446 | In distribution | |
| 611807 | In distribution | |
| 610449 | In distribution | |
| 610479 | In distribution | |
| 610237 | In distribution | |
| 610231 | In distribution | |
| 611814 | In distribution | |
| 611782 | Withdrawn | |
| 610455 | Withdrawn | |
| 610474 | Withdrawn | |
| 610494 | Withdrawn | |
| 610473 | Withdrawn | |
| 610499 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Z-MED II™ | B. Braun Interventional Systems, Inc. | 33 |
| True Dilatation | Bard Peripheral Vascular, Inc. | 18 |
| Inoue Balloon A | Toray Industries, Inc. | 12 |
| V8 | Intervalve, Inc. | 12 |
| KardiaPSI | Intervention Tech, Inc. ; dba Corvention | 11 |
| NuCLEUS-X™ | B. Braun Interventional Systems, Inc. | 9 |
| ValvuloPro® | Dongguan TT Medical, Inc. | 6 |
| Vida® | Bard Peripheral Vascular, Inc. | 5 |
| True Flow | Bard Peripheral Vascular, Inc. | 5 |
| OutFlo Aortic Valve Valvuloplasty Dilatation Balloon Catheter | Disa Medinotec (PTY) Ltd | 5 |
| Edwards Balloon Catheter | Edwards Lifesciences Technology Sarl | 1 |
| Ascendra Balloon Aortic Valvuloplasty Catheter | Edwards Lifesciences Technology Sarl | 1 |
Showing 12 of 15. All products under Balloon Aortic Valvuloplasty
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.