Millipede 088 Access Catheter
Basic Information
- Brand Name
- Millipede 088 Access Catheter
- Primary DI
- 05391539370111
- Version / Model
- 1.2
- Catalog Number
- PMA088120US
- Company Name
- PERFUZE LIMITED
- Labeler DUNS
- 985715471
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-02
- Public Version
- 1
- Public Version Date
- 2023-11-10
- Public Version Status
- New
- Public Device Record Key
- d662819a-7c07-469e-ac38-edbc5db05baf
Device Description
The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO). The Millipede 088 Access Catheter is a single lumen, coil-reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature
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 |
|---|---|---|---|---|
| QJP | Catheter, Percutaneous, Neurovasculature | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17846 | Vascular guide-catheter, single-use | A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391539370111 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231802 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Inner Diameter | 2.24 | Millimeter | |
| Catheter Gauge | 8 | French | |
| Catheter Working Length | 119 | Centimeter |