Device
Volante Steerable Sheath 6.5Fr, 55cm Sheath Length, 17mm Curve Bend
Manufacturer
Oscor Inc.
Oscor Inc.
Model: VLT-6.5-55-17-S
Catalog: VLT-6.5-55-17-S
DI: 00885672012946
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
Volante Steerable Sheath 6.5Fr, 55cm Sheath Length, 17mm Curve Bend
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5e9bf76c-ca0e-4e99-b2d2-efbbbb5880c2
Distribution Status:
In Commercial Distribution
DUNS Number:
101835833
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:
00885672012946
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:
K140406
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Centimeter
Item #1 - Size - @attributes - Value:
55
Item #1 - Size Type:
Length
Item #2 - Size Text:
6.5 F
Item #2 - Size Type:
Device Size Text, specify