Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
FDA 510(k) K181529 · Contego Medical, LLC
510(k) numberK181529
Submission
- Device name
- Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
- Applicant
- Contego Medical, LLC
Raleigh, NC, US - Received
- June 11, 2018
- Decision date
- December 6, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIT – Catheter, Angioplasty, Peripheral, Transluminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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|---|---|---|---|
| K260304 | WAVE PTA Balloon CatheterLIT · Traditional | WAVE Medical AG | 05/20/2026SE |
| K252512 | Armada 14 NC PTA CatheterLIT · Traditional | Abbott Medical | 02/13/2026SE |
| K251915 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | Natec Medical , Ltd. | 12/18/2025SE |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…LIT · Special | Biotronik, Inc. | 04/04/2025SE |
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…LIT · Traditional | Brosmed Medical Co., Ltd. | 02/27/2025SE |
| K241040 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | Natec Medical , Ltd. | 12/18/2024SE |
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterLIT · Traditional | Creagh Medical Ltd. Dba Surmodics, Inc. | 11/15/2024SE |
| K241740 | Finesse Injectable PTA Balloon Dilatation CatheterLIT · Special | Summa Therapeutics | 07/16/2024SE |
| K241711 | Oscar Peripheral Multifunctional Catheter systemLIT · Special | Biotronik, Inc. | 07/11/2024SE |
| K241683 | Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling…LIT · Special | Boston Scientific Corporation | 07/10/2024SE |
More from Boston Scientific Corporation
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| K251485 | Excipio LV Prime Thrombectomy DeviceQEW · Special | 06/13/2025SE |
| K230030 | Excipio SV Aspiration Catheter and TubingQEW · Traditional | 05/30/2023SE |
| K223897 | Excipio LV Thrombectomy DeviceQEW · Traditional | 02/17/2023SE |
| K221204 | Excipio SV Thrombectomy DeviceQEW · Traditional | 06/23/2022SE |
| K221339 | Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionLIT · Special | 06/09/2022SE |
| K181128 | Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…LIT · Traditional | 09/06/2018SE |
Questions and answers
When was Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection cleared by the FDA?
Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection (K181529) received a 510(k) decision of Substantially Equivalent on December 6, 2018, 178 days after the submission was received.
What is the product code of K181529?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.