FDA UDI
In Commercial Distribution
🇺🇸 United States
AGENT™
DI: 00191506014841
·
Model: H7493960820400
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AGENT™
- Primary DI
- 00191506014841
- Version / Model
- H7493960820400
- Catalog Number
- H7493960820400
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-21
- Public Version
- 2
- Public Version Date
- 2026-03-04
- Public Version Status
- Update
- Public Device Record Key
- c89d6a0f-eb19-4a43-a5e2-2aba8c2ac688
Device Description
Paclitaxel-Coated Balloon Catheter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| OOB | Drug-eluting percutaneous transluminal coronary angioplasty catheter | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62218 | Coronary angioplasty balloon catheter, drug-coated | A flexible tube with a drug coating at its distal end designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate an atherosclerotic stenotic coronary artery by controlled inflation of a distal distensible balloon, and to simultaneously release a drug intended to inhibit restenosis. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. It may be available as an over-the-wire (OTW) or a rapid exchange (RX) type, and devices to assist catheterization may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191506014841 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P230035 | 000 |
| P230035 | 006 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Balloon Length | 20 | Millimeter | |
| Balloon Diameter | 4 | Millimeter |