XO Score
- Primary DI
- B090S6500650
- Brand
- XO Score
- Company
- ZIEN MEDICAL TECHNOLOGIES, INC.
- Model
- S6.50-065
- Catalog number
- S6.50-065
- Device description
- The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
- Published
- 2022-06-20
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring | Cardiovascular | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B090S6500651 | Package | HIBCC | 1 | In Commercial Distribution |
| B090S6500652 | Package | HIBCC | 5 | In Commercial Distribution |
| B090S6500650 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Peripheral angioplasty balloon catheter, basic | A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Catheter Gauge | 6.4 | French |
| Catheter Working Length | 65 | Centimeter |
| Device Size Text, specify | 0 | |
| Introducer Sheath Compatibilit | 7 | French |
Regulatory Flags#
- DUNS number
- 017535668
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00850068519279 | SAM Medical | IO805 | IO805 | 2026-05-07 |
| 00850068519309 | SAM Medical | IO806 | IO806 | 2026-05-07 |
| 00850068519330 | SAM Medical | IO807 | IO807 | 2026-05-07 |
| B090MT630 | MorTan | MT63 | 2026-02-17 | |
| B090MT2020 | MorTan | MT202 | 2026-02-10 | |
| B090MT2021 | MorTan | MT202 | 2026-02-10 | |
| B090XC2201450 | XO Constrain | XC2.20-145 | 2026-02-03 | |
| B090XC2201451 | XO Constrain | XC2.20-145 | 2026-02-03 | |
| 00850068519231 | SAM Medical | IO842 | 2025-12-09 | |
| 00850068519248 | SAM Medical | IO847W-1P | 2025-12-09 | |
| 00850068519255 | SAM Medical | IO846W-1P | 2025-12-09 | |
| 00850068519262 | SAM Medical | IO845W-1P | 2025-12-09 | |
| 10850068519238 | SAM Medical | IO842 | 2025-12-09 | |
| 10850068519245 | SAM Medical | IO847W-1P | 2025-12-09 | |
| 10850068519252 | SAM Medical | IO846W-1P | 2025-12-09 | |
| 10850068519269 | SAM Medical | IO845W-1P | 2025-12-09 | |
| B090P110900 | VentiV Scientific | P11-090 | P11-090 | 2025-11-24 |
| B090P11090F0 | VentiV Scientific | P11-090-F | P11-090-F | 2025-11-24 |
| B090P110901 | VentiV Scientific | P11-090 | P11-090 | 2025-11-24 |
| B090P11090F1 | VentiV Scientific | P11-090-F | P11-090-F | 2025-11-24 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06923533801057 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-05-15 |
| B090XC2201450 | XO Constrain | ZIEN MEDICAL TECHNOLOGIES, INC. | PNO | 2026-02-03 |
| B090XC2201451 | XO Constrain | ZIEN MEDICAL TECHNOLOGIES, INC. | PNO | 2026-02-03 |
| 06972253606060 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606084 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606107 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606121 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606145 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606183 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606206 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606220 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606268 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606329 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606343 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606367 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606404 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606428 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606442 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606466 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253606480 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-30 |
| 06972253605780 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-24 |
| 06972253605797 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-24 |
| 06972253605803 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-24 |
| 06972253605810 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-24 |
| 06972253605827 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-24 |
| 06972253605834 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-24 |
| 06972253605841 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-24 |
| 06972253605858 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-24 |
| 06972253605865 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-24 |
| 06972253605872 | PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2025-07-24 |