Model: 31510140
DI: 06970226523208
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
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2965fb10-7049-4fc5-8eb8-b8b0abd972f9
Distribution Status:
In Commercial Distribution
DUNS Number:
118745817
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
Item #1 - Device ID:
16970226523205
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
12
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
06970226523208
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
06970226523208
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 17184
Name: Peripheral angioplasty balloon catheter, basic
Definition:
A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
FDA Product Codes
LIT
Catheter, Angioplasty, Peripheral, Transluminal
Premarket Submissions
Submission Number:
K171290
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Centimeter
Item #1 - Size - @attributes - Value:
140
Item #1 - Size Type:
Catheter Working Length
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
1.5
Item #2 - Size Type:
Balloon Diameter
Item #3 - Size - @attributes - Unit:
Millimeter
Item #3 - Size - @attributes - Value:
10
Item #3 - Size Type:
Balloon Length