FDA UDI
In Commercial Distribution
🇺🇸 United States
pRESET® Thrombectomy Device (4mm x 20mm)
DI: 05391530910002
·
Model: PRE-4-20
·
PHENOX LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- pRESET® Thrombectomy Device (4mm x 20mm)
- Primary DI
- 05391530910002
- Version / Model
- PRE-4-20
- Company Name
- PHENOX LIMITED
- Labeler DUNS
- 985621869
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-24
- Public Version
- 1
- Public Version Date
- 2023-02-01
- Public Version Status
- New
- Public Device Record Key
- 12910e5c-44a8-4ee6-ba8f-d6343eaa6aee
Device Description
The pRESET Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The device is designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and middle cerebral artery (MCA).
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
- MR Unsafe
- 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 |
| POL | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | Neurology | 882.5600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61779 | Thrombectomy wire-net | A device intended to be percutaneously introduced into the vasculature (coronary, peripheral and/or intracranial) through an appropriate intravascular catheter for the removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction; revascularization may also be achieved through thrombus reorientation. Also referred to as a stent retriever or clot retrieval catheter, it consists of an expanding, stent-like wire net connected to a pusher wire primarily intended to grip and remove the emboli/thrombi; it might include a guide-catheter dedicated to introduction of the wire-net. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391530910002 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222848 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 4mm x 20mm |