Transonic
12 catalogue numbers from ADT1001-10, listed by Transonic Systems, Inc., United States, under Catheter, Flow Directed. 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 Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
Record
| Listed by | Transonic Systems, Inc., United States |
|---|---|
| FDA product code | DYG |
| Device type | Catheter, Flow Directed |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1240 |
| Establishment | Manufacturer |
| Record published | 2016-04-28 |
| Record revised | 2021-11-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2021-11-02 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ADT1001-10 | 10 | In distribution | |
| HVT100 | In distribution | ||
| ADT1002-10 | 10 | In distribution | |
| HVT101 | In distribution | ||
| ADT1002-10 | Withdrawn | ||
| ADT1004 | Withdrawn | ||
| ADT1001-10 | Withdrawn | ||
| HVT101 | Withdrawn | ||
| ADT1001 | Withdrawn | ||
| ADT1002 | Withdrawn | ||
| ADT1004-10 | Withdrawn | ||
| HVT100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 115 |
| Corodyn | B. Braun Medical Inc. | 10 |
| Venos Occlusion Balloon Catheter | Oscor Inc. | 9 |
| Swan-Ganz True Size | Edwards Lifesciences Technology Sarl | 9 |
| Graftmaster | Abbott Vascular | 9 |
| Swan-Ganz | Edwards Lifesciences Technology Sarl | 7 |
| Pruitt Occlusion Catheter | Lemaitre Vascular, Inc. | 6 |
| Swan-Ganz VIP | Edwards Lifesciences Technology Sarl | 3 |
| Swan-Ganz | Becton, Dickinson AND Company | 3 |
| Swan Ganz Catheter | Edwards Lifesciences Technology Sarl | 2 |
| Swan-Ganz Ccombo | Edwards Lifesciences Technology Sarl | 2 |
| Cook | Cook Incorporated | 2 |
Showing 12 of 23. All products under Catheter, Flow Directed
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K010253 | 2002-03-19 |
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.