ICHOR
- Primary DI
- 00860010378007
- Company
- ICHOR VASCULAR, INC.
- Model
- ICH14FR
- Device description
- The ICHOR embolectomy system is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The device is intended for peripheral vasculature
- Published
- 2023-10-13
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 074702488
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00860010378007 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 00860010378007 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| DXE | Catheter, Embolectomy | 2 | Cardiovascular | 870.5150 | N | Eligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K230743 | 000 | ICHOR 14F Embolectomy System | Ichor | 2023-09-05 | QEW |
GMDN Terms
| Term | Definition |
|---|
| Thrombectomy balloon catheter | A flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through distension of a balloon intended to dilate the stenosis. It is a balloon catheter that may include valves for the injection of contrast media/thrombolytic agents and/or an embolectomy coil for mechanical removal of the obstruction. This is a single-use device. |
Device Sizes
| Type | Value | Text |
|---|
| Catheter Gauge | 14 French | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 70 Degrees Fahrenheit | 75 Degrees Fahrenheit | |
Contacts
| Phone | Email |
|---|
| 9544834525 | tblair34@gmail.com |
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| B729ICH7FR0 | ICHOR | ICH7FR | | 2019-07-31 |
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