Stellar Guide Catheter N/A

GUDID 00840303713579

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.

BALT USA LLC

Vascular guide-catheter, single-use

• Primary Device ID: 00840303713579
• NIH Device Record Key: ed64161d-da64-4a89-bd25-351ef83b0350
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stellar Guide Catheter
• Version Model Number: STLR074110
• Catalog Number: N/A
• Company DUNS: 945543689
• Company Name: BALT USA LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com

Device Dimensions

• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter
• Length: 110 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840303713579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234074

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-17
• Device Publish Date: 2025-06-09

On-Brand Devices [Stellar Guide Catheter]

• 00840303709671: The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. T
• 00840303709664: The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. T
• 00840303709657: The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. T
• 00840303709640: The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. T
• 00840303709633: The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. T
• 00840303709626: The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. T
• 00840303709619: The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. T
• 00840303713586: Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The d
• 00840303713579: Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The d
• 00840303713562: Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The d
• 00840303713555: Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The d
• 00840303713548: Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The d
• 00840303713531: Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The d