FDA UDI
In Commercial Distribution
🇺🇸 United States
Flextome® Cutting Balloon®
DI: 08714729808664
·
Model: H749CBO3400100
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Flextome® Cutting Balloon®
- Primary DI
- 08714729808664
- Version / Model
- H749CBO3400100
- Catalog Number
- H749CBO3400100
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 39dd18e1-9144-42ef-833c-644f775d1639
Device Description
Microsurgical Dilatation Device
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 |
|---|---|---|---|---|
| NWX | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44088 | Coronary angioplasty balloon catheter, cutting/scoring | A sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery and increase myocardial perfusion, by controlled inflation of a distensible balloon at its distal tip with peripheral cutting/scoring elements (e.g., microsurgical atherotomes) intended to remove stenotic material. The device is typically placed using a guidewire and guiding catheter, and its balloon is inflated by the infusion of liquid through it tubular body. The tube and balloon are typically made of polymer materials and the cutting/scoring elements are typically made of metal [e.g., nickel-titanium alloy (Nitinol)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729808664 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P950020 | 010 |
| P950020 | 011 |
| P950020 | 012 |
| P950020 | 013 |
| P950020 | 014 |
| P950020 | 015 |
| P950020 | 017 |
| P950020 | 032 |
| P950020 | 036 |
| P950020 | 055 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 10 mm Length | ||
| Device Size Text, specify | 4.0 mm Diameter |