VersaCross Connect Laac Access Solution
1 x VersaCross Connect Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use)); 1 x Dispersive Electrode
1manufacturer
16catalogue 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 | 2022-08-12 |
| Record revised | 2023-12-08 (version 5) |
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 | 2023-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VXAK0015 | 12F 85cm VersaCross Connect Transseptal Dilator with Large curve D1 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 230cm J-Tip VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | In distribution |
| VXAK0003 | 12F 85cm VersaCross Connect Transseptal Dilator with Large curve D1 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 180cm Pigtail VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | In distribution |
| VXAK0005 | 12F 85cm VersaCross Connect Transseptal Dilator with standard curve D0 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 230cm Pigtail VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | In distribution |
| VXAK0007 | 12F 85cm VersaCross Connect Transseptal Dilator with Large curve D1 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 230cm Pigtail VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | In distribution |
| VXAK0001 | 12F 85cm VersaCross Connect Transseptal Dilator with standard curve D0 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 180cm Pigtail VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | In distribution |
| VXAK0009 | 12F 85cm VersaCross Connect Transseptal Dilator with standard curve D0 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 180cm J-tip VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | In distribution |
| VXAK0015 | 12F 85cm VersaCross Connect Transseptal Dilator with Large curve D1 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 230cm J-Tip VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | Withdrawn |
| VXAK0011 | 12F 85cm VersaCross Connect Transseptal Dilator with Large curve D1 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 180cm J-Tip VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | Withdrawn |
| VXAK0009 | 12F 85cm VersaCross Connect Transseptal Dilator with standard curve D0 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 180cm J-tip VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | Withdrawn |
| VXAK0013 | 12F 85cm VersaCross Connect Transseptal Dilator with standard curve D0 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 230cm J-tip VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | Withdrawn |
| VXAK0001 | 12F 85cm VersaCross Connect Transseptal Dilator with standard curve D0 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 180cm Pigtail VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | Withdrawn |
| VXAK0003 | 12F 85cm VersaCross Connect Transseptal Dilator with Large curve D1 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 180cm Pigtail VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | Withdrawn |
| VXAK0005 | 12F 85cm VersaCross Connect Transseptal Dilator with standard curve D0 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 230cm Pigtail VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | Withdrawn |
| VXAK0013 | 12F 85cm VersaCross Connect Transseptal Dilator with standard curve D0 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 230cm J-tip VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | Withdrawn |
| VXAK0011 | 12F 85cm VersaCross Connect Transseptal Dilator with Large curve D1 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 180cm J-Tip VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | Withdrawn |
| VXAK0007 | 12F 85cm VersaCross Connect Transseptal Dilator with Large curve D1 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 230cm Pigtail VersaCross RF Wire OD=0.035in (10ft (3m) Connector Cable) | 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.