Serranator PTA Serration Balloon Catheter
FDA 510(k) K193181 · Cagent Vascular, LLC
510(k) numberK193181
Submission
- Device name
- Serranator PTA Serration Balloon Catheter
- Applicant
- Cagent Vascular, LLC
Wayne, PA, US - Received
- November 18, 2019
- Decision date
- April 15, 2020
- 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 |
More from Cagent Vascular, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K220704 | Serranator PTA Serration Balloon CatheterPNO · Traditional | 05/04/2022SE |
| K213728 | Serranator PTA Serration Balloon CatheterPNO · Special | 12/15/2021SE |
| K203437 | Serranator PTA Serration Balloon CatheterPNO · Special | 12/22/2020SE |
| K163380 | Serranator Alto PTA Serration Balloon CatheterPNO · Traditional | 02/13/2017SE |
Questions and answers
When was Serranator PTA Serration Balloon Catheter cleared by the FDA?
Serranator PTA Serration Balloon Catheter (K193181) received a 510(k) decision of Substantially Equivalent on April 15, 2020, 149 days after the submission was received.
What is the product code of K193181?
The FDA product code is PNO – Catheter, Percutaneous, Cutting/Scoring, a Class II (moderate risk) device regulated under 21 CFR 870.1250.