V8
V8 Balloon Aortic Valvuloplasty Catheter, 192412C110
1manufacturer
12catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
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 | Intervalve, Inc., United States |
|---|---|
| FDA product code | OZT |
| Device type | Balloon Aortic Valvuloplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1255 |
| Record published | 2016-09-08 |
| Record revised | 2018-09-10 (version 3) |
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 | Storage environment temperature -20 to 60 °C |
| Distribution end date | 2018-09-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V8-1924 | 19mm | Withdrawn |
| TAV8-2328 | 23mm | Withdrawn |
| TAV8-1924 | 19mm | Withdrawn |
| 192412C110 | 19mm | Withdrawn |
| V8-2126 | 21mm | Withdrawn |
| TAV8-2126 | 21mm | Withdrawn |
| V8-1722 | 17mm | Withdrawn |
| 212612C110 | 21mm | Withdrawn |
| V8-2328 | 23mm | Withdrawn |
| 172212C110 | 17mm | Withdrawn |
| TAV8-1722 | 17mm | Withdrawn |
| 232812C110 | 23mm | Withdrawn |
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 |
| Inoue Balloon A | Toray Industries, 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 |
|---|---|
| K152150 | 2015-12-18 |
| K150343 | 2015-04-03 |
| K133607 | 2014-02-11 |
| K132728 | 2013-11-22 |
| K123111 | 2013-01-31 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-03-14 | Class II | Nonconforming Material/Component | Leak issues were discovered through accelerated age testing. | 2 | 2014-06-16 |
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.