Device
Reprocessed VersaCross RF Wire and Connector Cable 180 cm Pigtail
Manufacturer
INNOVATIVE HEALTH LLC
INNOVATIVE HEALTH LLC
Model: N/A
Catalog: VXW-35-180-P
DI: 10841898137327
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
Reprocessed VersaCross RF Wire and Connector Cable 180 cm Pigtail
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4618d028-aa0c-4958-a56b-917ff741c967
Distribution Status:
In Commercial Distribution
DUNS Number:
015575953
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
10841898137327
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65069
Name: Cardiac transseptal access electrosurgical catheter, reprocessed
Definition:
A flexible tube intended to be used during a transseptal catheterization procedure to: 1) apply radio-frequency alternating current in a monopolar configuration, to puncture the interatrial septum and gain access to the left atrium; and 2) provide a fluid path to facilitate aspiration, injection/infusion, blood sampling, and/or pressure monitoring; it is not intended for cardiac ablation or to accommodate a needle in its lumen. It has a distal monopolar electrode. This is a previously used single-use device that has been processed for an additional single-use patient application.
FDA Product Codes
QLZ
Septostomy Catheter, Reprocessed
Premarket Submissions
Submission Number:
K213584
Supplement Number:
000