Stellar Guide Catheter

Basic Information

• Brand Name: Stellar Guide Catheter
• Primary DI: 00840303713579
• Version / Model: STLR074110
• Catalog Number: N/A
• Company Name: BALT USA LLC
• Labeler DUNS: 945543689
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-09
• Public Version: 1
• Public Version Date: 2025-06-17
• Public Version Status: New
• Public Device Record Key: ed64161d-da64-4a89-bd25-351ef83b0350

Device Description

Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The distal tip of the catheter shaft includes a marker band while the proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the system. The Stellar Guide Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Stellar Guide Catheter is visible under fluoroscopy. The Stellar Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. A peelable split introducer sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Stellar Guide Catheter into an appropriate vascular sheath. The catheter and introducer sheath are provided sterile, non-pyrogenic, and are intended for single use use only.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQY	Catheter, Percutaneous	Cardiovascular	870.1250	2
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17846	Vascular guide-catheter, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840303713579	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K234074	000

Device Sizes

Type	Value	Unit	Text
Length	110	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store the Stellar Guide Catheter in a cool, dry, place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.