Inoue Balloon A
12 catalogue numbers from PTAV-16R, listed by Toray Industries, Inc., Japan, under Balloon Aortic Valvuloplasty. 1 manufacturer in China is registered for this product code.
1manufacturer
12catalogue numbers in this listing
1510(k) clearance
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 | Toray Industries, Inc., Japan |
|---|---|
| FDA product code | OZT |
| Device type | Balloon Aortic Valvuloplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1255 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2023-06-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a cool, dry, dark place. |
| Sizes | Length 105 cm; catheter gauge 10 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PTAV-16R | Length 105 cm | In distribution |
| PTAV-26RP | Length 105 cm | In distribution |
| PTAV-26R | Length 105 cm | In distribution |
| PTAV-18R | Length 105 cm | In distribution |
| PTAV-20RP | Length 105 cm | In distribution |
| PTAV-20R | Length 105 cm | In distribution |
| PTAV-22RP | Length 105 cm | In distribution |
| PTAV-16RP | Length 105 cm | In distribution |
| PTAV-24R | Length 105 cm | In distribution |
| PTAV-22R | Length 105 cm | In distribution |
| PTAV-24RP | Length 105 cm | In distribution |
| PTAV-18RP | Length 105 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Z-MED™ | B. Braun Interventional Systems, Inc. | 60 |
| Z-MED II™ | B. Braun Interventional Systems, Inc. | 33 |
| True Dilatation | Bard Peripheral Vascular, Inc. | 18 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220881 | 2022-12-18 |
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.