VersaCross Large Access Transseptal Dilator
1 x VersaCross Large Access Transseptal Dilator; 1 x J-Tip Guidewire
1manufacturer
4catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifetech Scientific (Shenzhen) Co,.ltd | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Baylis Médicale Cie Inc |
|---|---|
| FDA product code | DRE |
| Device type | Dilator, Vessel, For Percutaneous Catheterization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1310 |
| Record published | 2021-06-10 |
| Record revised | 2025-11-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-02-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VLA125-35-85-D1 | 12.5F 85cm Transseptal Dilator with large curve D1 and max OD = 4.17mm; 180cm J-Tip Guidewire with OD = 0.035 inch (0.89mm) and tip shape = 3mm J | Withdrawn |
| VLA125-35-67-D1 | 12.5F 67cm Transseptal Dilator with large curve D1 and max OD = 4.17mm; 180cm J-Tip Guidewire with OD = 0.035 inch (0.89mm) and tip shape = 3mm J | Withdrawn |
| VLA125-35-67-D0 | 12.5F 67cm Transseptal Dilator with standard curve D0 and max OD = 4.17mm; 180cm J-Tip Guidewire with OD = 0.035 inch (0.89mm) and tip shape = 3mm J | Withdrawn |
| VLA125-35-85-D0 | 12.5F 85cm Transseptal Dilator with standard curve D0 and max OD = 4.17mm; 180cm J-Tip Guidewire with OD = 0.035 inch (0.89mm) and tip shape = 3mm J | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prelude® | Merit Medical Systems, Inc. | 323 |
| Prelude PRO™ | Merit Medical Systems, Inc. | 132 |
| Cook | Cook Incorporated | 125 |
| Avanti | Cordis Corp. | 81 |
| Dilator, Vessel, For Percutaneous Catheterization | B. Braun Interventional Systems, Inc. | 59 |
| Merit MAK™ | Merit Medical Systems, Inc. | 49 |
| Prelude ACT™ | Merit Medical Systems, Inc. | 38 |
| AngioDynamics | Navilyst Medical, Inc. | 38 |
| Super Sheath | Togo Medikit Co., Ltd. | 31 |
| Avanti | Cordis US Corp. | 29 |
| Mini Stick MAX | AngioDynamics, Inc. | 28 |
| OneStic Micro-Access Introducer | Argon Medical Devices, Inc. | 27 |
Showing 12 of 159. All products under Dilator, Vessel, For Percutaneous Catheterization
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.