True Dilatation
TRUE™ DILATATION Balloon Valvuloplasty Catheter, 18 mm x 4.5 cm, 110 cm catheter
1manufacturer
18catalogue 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 | Bard Peripheral Vascular, Inc., United States |
|---|---|
| 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 | 2016-09-06 |
| Record revised | 2018-03-29 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0234512 | Balloon Diameter, 23 Millimeters | In distribution |
| 0224512 | Shaft Length, 110 Centimeters | In distribution |
| T284514 | Balloon Length, 4.5 Centimeters | In distribution |
| T224512 | Shaft Length, 55 Centimeters | In distribution |
| 0284514 | Balloon Diameter, 28 Millimeters | In distribution |
| 0244512 | Balloon Length, 4.5 Centimeters | In distribution |
| T244512 | Shaft Length, 55 Centimeters | In distribution |
| 0184511 | Shaft Length, 110 Centimeters | In distribution |
| T184511 | Balloon Diameter, 18 Millimeters | In distribution |
| 0214512 | Balloon Length, 4.5 Centimeters | In distribution |
| T254513 | Balloon Length, 4.5 Centimeters | In distribution |
| 0264513 | Balloon Length, 4.5 Centimeters | In distribution |
| T234512 | Balloon Diameter, 23 Millimeters | In distribution |
| T204511 | Balloon Diameter, 20 Millimeters | In distribution |
| 0254513 | Balloon Diameter, 25 Millimeters | In distribution |
| T214512 | Shaft Length, 55 Centimeters | In distribution |
| 0204511 | Shaft Length, 110 Centimeters | In distribution |
| T264513 | Balloon Length, 4.5 Centimeters | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133569 | 2013-12-20 |
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.