Angiosculpt Scoring Balloon Catheter
FDA 510(k) K050629 · Angioscore, Inc.
510(k) numberK050629
Submission
- Device name
- Angiosculpt Scoring Balloon Catheter
- Applicant
- Angioscore, Inc.
Alameda, CA, US - Received
- March 11, 2005
- Decision date
- September 2, 2005
- 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 |
|---|---|---|
| K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingPNO · Special | 03/04/2015SE |
| K133998 | Angiosculpt Pta Scoring Balloon with Hydrocross CaotingPNO · Traditional | 04/18/2014SE |
| K122685 | Angiosculpt Pta Scoring Balloon CatheterPNO · Traditional | 01/11/2013SE |
| K112182 | Angiosculpt Pta Scoring Balloon CatheterPNO · Special | 08/26/2011SE |
| K110767 | Angiosculpt Pta Scoring Balloon CatheterPNO · Special | 04/15/2011SE |
| K101735 | Angiosculpt Pta Scoring Balloon Catheter Model 2039-XXYY, 2155-XXYYPNO · Special | 07/14/2010SE |
| K100303 | Angiosculpt Pta Scoring Balloon Catheter Model 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYYPNO · Traditional | 03/22/2010SE |
| K091966 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040PNO · Special | 07/30/2009SE |
| K082059 | Angiosculpt Pta Scoring Balloon CatheterPNO · Special | 08/11/2008SE |
| K081220 | Modification to Angiosculpt Pta Scoring Balloon CatheterPNO · Special | 05/28/2008SE |
Questions and answers
When was Angiosculpt Scoring Balloon Catheter cleared by the FDA?
Angiosculpt Scoring Balloon Catheter (K050629) received a 510(k) decision of Substantially Equivalent on September 2, 2005, 175 days after the submission was received.
What is the product code of K050629?
The FDA product code is PNO – Catheter, Percutaneous, Cutting/Scoring, a Class II (moderate risk) device regulated under 21 CFR 870.1250.