Splitwire Percutaneous Transluminal Angioplasty Scoring Device
FDA 510(k) K113103 · Rex Medical
510(k) numberK113103
Submission
- Device name
- Splitwire Percutaneous Transluminal Angioplasty Scoring Device
- Applicant
- Rex Medical
Great Neck, NY, US - Received
- October 19, 2011
- Decision date
- May 22, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PNO – Catheter, Percutaneous, Cutting/Scoring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material
Other 510(k)s with product code PNO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260012 | UltraScore Focused Force PTA BalloonPNO · Special | Bard Peripheral Vascular, Inc. | 02/04/2026SE |
| K243944 | Aperta NSE PTA Balloon Dilatation CatheterPNO · Traditional | Goodman Co., Ltd. | 04/22/2025SE |
| K242254 | D·Kutting LL Peripheral Scoring Balloon Dilatation CatheterPNO · Traditional | Dk Medical Technology Co., Ltd. | 04/21/2025SE |
| K241478 | Tri-Wedge PTA Scoring Balloon Dilatation CatheterPNO · Traditional | Brosmed Medical Co., Ltd. | 10/22/2024SE |
| K232258 | XO Constrain Percutaneous Transluminal Angioplasty Constraining CatheterPNO · Traditional | Transit Scientific, LLC | 06/17/2024SE |
| K232013 | Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…PNO · Traditional | Goodman Co., Ltd. | 03/28/2024SE |
| K232207 | D·Kutting PTA Scoring Balloon Dilatation CatheterPNO · Traditional | Dk Medical Technology Co., Ltd. | 03/07/2024SE |
| K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterPNO · Special | Transit Scientific, LLC | 10/18/2022SE |
| K220704 | Serranator PTA Serration Balloon CatheterPNO · Traditional | Cagent Vascular, LLC | 05/04/2022SE |
| K213728 | Serranator PTA Serration Balloon CatheterPNO · Special | Cagent Vascular, LLC | 12/15/2021SE |
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| K081410 | Option Vena Cava FilterDTK · Traditional | 06/04/2009SE |
| K071422 | 15.5F Hemo-Stream Hemodialysis Catheter SetMSD · Traditional | 08/22/2007SESK |
| K051468 | Inner-Lock Introducer SheathDYB · Special | 08/04/2005SE |
| K040252 | Cleaner Rotational Thrombectomy System KitMCW · Special | 02/26/2004SE |
| K033793 | Cleaner II Rotational Thrombectomy SystemMCW · Traditional | 12/16/2003SE |
| K032569 | Short Introducer SheathDYB · Special | 09/16/2003SE |
| K031610 | Rex Medical Cleaner Rotational Thrombectomy SystemMCW · Traditional | 05/27/2003SE |
Questions and answers
When was Splitwire Percutaneous Transluminal Angioplasty Scoring Device cleared by the FDA?
Splitwire Percutaneous Transluminal Angioplasty Scoring Device (K113103) received a 510(k) decision of Substantially Equivalent on May 22, 2012, 216 days after the submission was received.
What is the product code of K113103?
The FDA product code is PNO – Catheter, Percutaneous, Cutting/Scoring, a Class II (moderate risk) device regulated under 21 CFR 870.1250.