Pruitt F3-S Carotid Shunt
FDA 510(k) K143454 · LeMaitre Vascular, Inc.
510(k) numberK143454
Submission
- Device name
- Pruitt F3-S Carotid Shunt
- Applicant
- LeMaitre Vascular, Inc.
Burlington, MA, US - Received
- December 3, 2014
- Decision date
- August 27, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MJN – Catheter, Intravascular Occluding, Temporary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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|---|---|---|---|
| K243795 | pREBOA-PRO CatheterMJN · Traditional | Prytime Medical Devices, Inc. | 09/05/2025SE |
| K251358 | Bridge Plus Occlusion Balloon (590-002)MJN · Traditional | Philips Image Guided Therapy Devices | 06/24/2025SE |
| K221294 | preCARDIA Occlusion SystemMJN · Traditional | Abiomed, Inc. | 06/30/2023SESU |
| K214060 | LANDMARK REBOA CatheterMJN · Traditional | Zien Medical Technologies, Inc. | 09/19/2022SE |
| K211610 | Fogarty Occlusion CatheterMJN · Traditional | Edwards Lifesciences, LLC | 02/14/2022SE |
| K212324 | RenovoCathMJN · Special | Renovorx, Inc. | 08/23/2021SE |
| K210602 | AortaSTAT Occlusion DeviceMJN · Traditional | Renalpro Medical, Inc. | 07/09/2021SE |
| K210358 | Neurescue deviceMJN · Traditional | Neurescue Aps | 05/21/2021SE |
| K201652 | COBRA-OS KitMJN · Traditional | Front Line Medical Technologies, Inc. | 02/22/2021SESK |
| K203540 | Bridge Occlusion BalloonMJN · Special | Spectranetics, Inc. | 12/23/2020SE |
More from Spectranetics, Inc.
| 510(k) | Device | Decision |
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| K212894 | PhasTIPPDWQ · Traditional | 03/31/2022SE |
| K190882 | XenoSure Biologic PatchPSQ · Traditional | 02/13/2020SE |
| K190267 | EZE SIT ValvulotomeMGZ · Traditional | 10/30/2019SE |
| K183513 | XenoSure Dura Biologic PatchGXQ · Traditional | 06/13/2019SE |
| K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt…MJN · Special | 11/16/2018SE |
| K173323 | AnastoClip GC Closure SystemFZP · Traditional | 03/08/2018SE |
| K152833 | Pruitt F3-S Polyurethane Carotid ShuntMJN · Traditional | 01/21/2016SE |
| K142660 | Antegrade LeMills ValvulotomeMGZ · Special | 10/17/2014SE |
| K140042 | 1.5MM Hydro Expandable Lemaitre ValvulotomeMGZ · Traditional | 04/10/2014SE |
| K133026 | Unballoon Non-Occlusion Modeling CatheterDQY · Traditional | 12/31/2013SE |
Questions and answers
When was Pruitt F3-S Carotid Shunt cleared by the FDA?
Pruitt F3-S Carotid Shunt (K143454) received a 510(k) decision of Substantially Equivalent on August 27, 2015, 267 days after the submission was received.
What is the product code of K143454?
The FDA product code is MJN – Catheter, Intravascular Occluding, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.4450.