Tigertriever 13 Revascularization Device
Basic Information
- Brand Name
- Tigertriever 13 Revascularization Device
- Primary DI
- 07290015107303
- Version / Model
- TRPP7144
- Catalog Number
- TRPP7144
- Company Name
- RAPID MEDICAL LTD
- Labeler DUNS
- 532702946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-28
- Public Version
- 2
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- 0f3c3c8c-8d97-40a8-9693-ee4cfa3337d7
Device Description
The Tigertriever 13 device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. The Tigertriever 13 Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.
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
- No
- 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 |
|---|---|---|---|---|---|---|
| Package | 17290015107300 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 07290015107303 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220808 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry place at room temperature in its designated box