FDA UDI
In Commercial Distribution
🇺🇸 United States
AGENT™
DI: 00191506014698
·
Model: H7493960812350
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- AGENT™
- Primary DI
- 00191506014698
- Version / Model
- H7493960812350
- Catalog Number
- H7493960812350
- 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
- d23dbe13-31b3-410a-b40a-fb1684dd98d8
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 | 00191506014698 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P230035 | 000 |
| P230035 | 006 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Balloon Length | 12 | Millimeter | |
| Balloon Diameter | 3.50 | Millimeter |