Raptor Aspiration Catheter
Basic Information
- Brand Name
- Raptor Aspiration Catheter
- Primary DI
- 00840303709404
- Version / Model
- RPTR074120
- Company Name
- BALT USA LLC
- Labeler DUNS
- 945543689
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-23
- Public Version
- 1
- Public Version Date
- 2024-07-31
- Public Version Status
- New
- Public Device Record Key
- 3aa0decc-327e-4383-bb26-b98502619c2f
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840303709404 | GS1 |
Customer Contacts
- Phone
- 1-949-788-1443
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K234083 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 120 | Centimeter | |
| Outer Diameter | 0.086 | Inch | |
| Catheter Inner Diameter | 0.074 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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