XO Score
- Primary DI
- B090S6500650
- Brand
- XO Score
- Company
- Zien Medical Technologies, LLC
- 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
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- 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 | 0 | |
| Catheter Working Length | 0 | |
| Device Size Text, specify | 0 | |
| Introducer Sheath Compatibilit | 0 |
Regulatory Flags#
- DUNS number
- 017535668
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| B0902P0130S0 | Knight Microcatheter | 2P0-130-S | 2P0-130-S | 2024-04-30 |
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| B090A90900 | Control 9F Mechanical Thrombectomy System, 90cm | A9-090 | A9-090 | 2022-06-29 |
| B090ARXLP60 | Control RX-LP Mechanical Thrombectomy System, 136cm | ARX-LP6 | ARX-LP6 | 2017-08-17 |
| B090ASP10010 | Control RX-LP Mechanical Thrombectomy System | ASP-1001 | ASP-1001 | 2023-04-26 |
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Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06923533801330 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801347 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801354 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801361 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801378 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801385 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801392 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801408 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801415 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801422 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801439 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801446 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801453 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801460 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801477 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801484 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801491 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801507 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801514 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801521 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801538 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801545 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801552 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801569 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801576 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801583 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801590 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801606 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801613 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |
| 06923533801620 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-07-30 |