Raptor Aspiration Catheter N/A

GUDID 00840303709398

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 ID00840303709398
NIH Device Record Key67efba81-5d68-4b5b-96a9-8ed8eeda2476
Commercial Distribution StatusIn Commercial Distribution
Brand NameRaptor Aspiration Catheter
Version Model NumberRPTR071132
Catalog NumberN/A
Company DUNS945543689
Company NameBALT USA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com

Device Dimensions

Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter
Catheter Inner Diameter0.071 Inch
Outer Diameter0.083 Inch
Length132 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 AgencyDevice ID
GS100840303709398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRYCatheter, Thrombus Retriever

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-31
Device Publish Date2024-07-23

On-Brand Devices [Raptor Aspiration Catheter]

00840303709411The Raptor Aspiration Catheter is a single-lumen, coil reinforced, variable stiffness composite
00840303709404The Raptor Aspiration Catheter is a single-lumen, coil reinforced, variable stiffness composite
00840303709398The Raptor Aspiration Catheter is a single-lumen, coil reinforced, variable stiffness composite
00840303709381The Raptor Aspiration Catheter is a single-lumen, coil reinforced, variable stiffness composite
00840303709602The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered
00840303709596The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered
00840303709589The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered
00840303709572The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered
00840303709565The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered
00840303709558The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered
00840303709541The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered
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