Raptor Aspiration Catheter N/A

GUDID 00840303709596

The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered in various sizes that facilitates removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Balt Aspiration Tubing Set. The distal tip of the catheter shaft includes a markerband and the proximal end of the catheter has a luer fitting to allow for the attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter. The Raptor Aspiration Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Raptor Aspiration Catheters are compatible with 0.014” – 0.018” guidewires and other interventional devices. A peelable split Introducer Sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Raptor Aspiration Catheter into an appropriate vascular sheath. The catheter and Introducer Sheath are provided sterile, non-pyrogenic, and intended for single use only.

BALT USA LLC

Thrombectomy suction catheter

• Primary Device ID: 00840303709596
• NIH Device Record Key: ae5c230d-e2b4-494e-93e9-d7f5f55289e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Raptor Aspiration Catheter
• Version Model Number: RPTR038155
• 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

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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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840303709596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243948

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: 2025-06-17
• Device Publish Date: 2025-06-09

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
• 00840303709602: The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered
• 00840303709596: The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered
• 00840303709589: The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered
• 00840303709572: The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered
• 00840303709565: The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered
• 00840303709558: The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered
• 00840303709541: The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered