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…
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.
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Raptor Aspiration Catheter | Listed by | Balt USA, LLC, United States |
| FDA product code | NRY |
| Device type | Catheter, Thrombus Retriever |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K234083 |
| Record published | 2024-07-23 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store the Raptor Aspiration Catheter in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extrem |
| Sizes | Catheter inner diameter 0.071 to 0.074 in; outer diameter 0.083 to 0.086 in; length 120 to 132 cm |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.