FDA UDI
In Commercial Distribution
🇺🇸 United States
FOGARTY
DI: 00690103043563
·
Model: 160245F
·
Edwards Lifesciences LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FOGARTY
- Primary DI
- 00690103043563
- Version / Model
- 160245F
- Catalog Number
- 160245F
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-03
- Public Version
- 4
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- c057f299-9195-4ba3-9d7a-d233b5b42195
Device Description
FOGARTY GRAFT THROMBECTOMY CATHETER, 5F 50CM
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MCW | Catheter, peripheral, atherectomy | Cardiovascular | 870.4875 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58174 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00690103043563 | GS1 |
Customer Contacts
- Phone
- +1(800)822-9637
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K942457 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | BODY LENGTH: 50CM, BODY DIAMETER: 5F (1.67MM), SPIRAL DIAMETER (EXTENDED): 5MM, SPIRAL DIAMETER (CONTRACTED): 16MM |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE IN A COOL, DRY PLACE.