Raptor Aspiration Catheter N/A

GUDID 00840303709381

The Raptor Aspiration Catheter is a single-lumen, coil reinforced, variable stiffness composite catheter that facilitates removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Balt Aspiration Tubing Set. The Raptor Aspiration Catheter is comprised of a hollow cylindrical tube which incorporates a standard luer fitting to allow attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter. The wall of the tube is constructed using a combination of metal coils and medical grade polymers. The distal portion of the Raptor Aspiration Catheter has a hydrophilic coating which provides a lubricious surface during use to aid in tracking through the vasculature. The distal tip of the catheter includes a radiopaque marker providing the user with visual confirmation of the distal tip location under fluoroscopy. The Raptor Aspiration Catheter is offered in various working lengths and nominal inner diameters and outer diameters.

BALT USA LLC

Thrombectomy suction catheter

• Primary Device ID: 00840303709381
• NIH Device Record Key: 85476d28-b8c0-4955-ac63-b3102e86613e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Raptor Aspiration Catheter
• Version Model Number: RPTR071128
• 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
• 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: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch
• Length: 128 Centimeter
• Outer Diameter: 0.083 Inch
• Catheter Inner Diameter: 0.071 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the Raptor Aspiration 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 Raptor Aspiration 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 Raptor Aspiration 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 Raptor Aspiration 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 Raptor Aspiration 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 Raptor Aspiration 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 Raptor Aspiration 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 Raptor Aspiration 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 Raptor Aspiration 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 Raptor Aspiration 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 Raptor Aspiration 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 Raptor Aspiration 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 Raptor Aspiration 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 Raptor Aspiration 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 Raptor Aspiration 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 Raptor Aspiration 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 Raptor Aspiration 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	00840303709381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234083

FDA Product Code

• NRY: Catheter, Thrombus Retriever

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: 2024-07-31
• Device Publish Date: 2024-07-23

On-Brand Devices [Raptor Aspiration Catheter]

• 00840303709411: The Raptor Aspiration Catheter is a single-lumen, coil reinforced, variable stiffness composite
• 00840303709404: The Raptor Aspiration Catheter is a single-lumen, coil reinforced, variable stiffness composite
• 00840303709398: The Raptor Aspiration Catheter is a single-lumen, coil reinforced, variable stiffness composite
• 00840303709381: The Raptor Aspiration Catheter is a single-lumen, coil reinforced, variable stiffness composite