510(k) K193495
- Device
- XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
- Applicant
- Transit Scientific
- 510(k) number
- K193495
- Product code
- PNO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-05-29
- Date received
- 2019-12-17
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous, Cutting/scoring
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jennifer Arnold
- Address
- 2757 S. 300 W, Suite E Salt Lake City UT US 84115 84115
FDA Registration Numbers#
- 3002807315
- 2183744
- 8043792
- 3016948450
- 3015002281
- 1313046
- 3012159165
- 3003775186
- 3027343398
- 1000533027
- 2124215
- 3002807314
- 2020394
- 3012696653
- 3005462046
- 1721676
- 3007835716
- 3021140368
- 3009756153
- 3015060261
- 3011826338
- 3014598164
- 1646831
- 2011171
- 1820334
- 1647149
- 3006082230
- 3030042169
- 1018233
- 3010391265
- 3000126629
- 9681260
Source Documents#
Other 510(k) Records For Product Code PNO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260012 | UltraScore™ Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | 2026-02-04 |
| K243944 | Aperta NSE PTA Balloon Dilatation Catheter | Goodman Co., Ltd. | 2025-04-22 |
| K242254 | D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | 2025-04-21 |
| K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2024-10-22 |
| K232258 | XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter | Transit Scientific, LLC | 2024-06-17 |
| K232013 | Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) | Goodman Co., Ltd. | 2024-03-28 |
| K232207 | D·Kutting™ PTA Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | 2024-03-07 |
| K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter | Transit Scientific, LLC | 2022-10-18 |
| K220704 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2022-05-04 |
| K213728 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2021-12-15 |
| K203437 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2020-12-22 |
| K202187 | FLEX Vessel Prep System | Venturemed Group, Inc. | 2020-09-11 |
| K193181 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2020-04-15 |
| K182713 | Scoreflex PTA Scoring Balloon Catheter | Orbusneich Medical Trading, Inc. | 2019-06-11 |
| K172571 | ULTRASCORE Focused Force PTA Balloon | C. R. Bard | 2017-09-22 |
Legacy Summary#
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FDA Review#
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