Model: D138505
Catalog: D138505
DI: 10846835026269
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
CARTO VIZIGO Bi-Directional Guiding Sheath
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e33bc2e3-7e91-46e5-ad75-e4aa4aa56ba3
Distribution Status:
In Commercial Distribution
DUNS Number:
020163218
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
10846835026269
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 17846
Name: Vascular guide-catheter, single-use
Definition:
A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
FDA Product Codes
DYB
Introducer, catheter
Premarket Submissions
Submission Number:
K170997
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling Low - @attributes - Value:
41
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling High - @attributes - Value:
77
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Do not use if package is damaged
Item #3 - Storage Handling Type:
Special Storage Condition, Specify
Item #3 - Storage Handling Special Condition Text:
Keep out of direct sunlight
Item #4 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #4 - Storage Handling Low - @attributes - Value:
5
Item #4 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #4 - Storage Handling High - @attributes - Value:
25
Item #4 - Storage Handling Type:
Storage Environment Temperature
Item #5 - Storage Handling Type:
Special Storage Condition, Specify
Item #5 - Storage Handling Special Condition Text:
Keep Dry