AccessGUDID - DEVICE: Raptor Aspiration Catheter (00840303709404)

GUDID

Device Identifier (DI) Information

Brand Name: Raptor Aspiration Catheter
Version or Model: RPTR074120
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BALT USA LLC

Primary DI Number: 00840303709404
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 945543689 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58173	Thrombectomy suction catheter	A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRY	Catheter, Thrombus Retriever

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K234083	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: 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

Clinically Relevant Size

[?]

Size Type Text
Length: 120 Centimeter
Outer Diameter: 0.086 Inch
Catheter Inner Diameter: 0.074 Inch

Device Record Status

Public Device Record Key: 3aa0decc-327e-4383-bb26-b98502619c2f
Public Version Date: July 31, 2024
Public Version Number: 1
DI Record Publish Date: July 23, 2024