Emboshield NAV6 Embolic Protection System
FDA 510(k) K081523 · Abbott Vascular-Vascular Solutions
Submission
- Device name
- Emboshield NAV6 Embolic Protection System
- Applicant
- Abbott Vascular-Vascular Solutions
Santa Clara, CA, US - Received
- June 2, 2008
- Decision date
- September 11, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NTE – Temporary Carotid Catheter For Embolic Capture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic…
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)NTE · Traditional | MicroVention, Inc. | 04/27/2023SE |
| K230402 | ENROUTE® Transcarotid Neuroprotection SystemNTE · Special | Silk Road Medical | 04/11/2023SE |
| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireNTE · Special | Cordis Corporation | 04/06/2022SE |
| K210282 | WIRION Embolic Protection SystemNTE · Special | Cardiovascular Systems, Inc. | 03/03/2021SE |
| K200198 | WirionNTE · Traditional | Cardiovascular Systems, Inc. | 03/18/2020SE |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresNTE · Traditional | Abbott Vascular | 07/25/2019SE |
| K180023 | WirionNTE · Traditional | Gardia Medical , Ltd. | 03/21/2018SE |
| K153485 | ENROUTE Transcarotid Neuroprotection SystemNTE · Traditional | Silk Road Medical, Inc. | 03/10/2016SE |
| K153086 | RX ACCUNET Embolic Protection SystemNTE · Special | Abbott Vascular | 11/20/2015SE |
| K143570 | WirionNTE · Traditional | Gardia Medical | 06/04/2015SE |
More from Gardia Medical
| 510(k) | Device | Decision |
|---|---|---|
| K090665 | Emboshield NAV6 Embolic Protection System-Small/Large, Model 22437-19/22438-19NTE · Special | 05/22/2009SE |
| K090509 | Foxcross .035 Pta Catheter 14 MM X 20MM X 80 CM, Model 10342-20, Foxcross .035 Pta…DQY · Special | 03/20/2009SE |
| K072708 | Absolute Pro .035 Self-Expanding Stent SystemFGE · Traditional | 08/18/2008SESU |
| K080264 | Modification to: Fox Plus Pta CatheterLIT · Special | 03/26/2008SE |
| K072798 | Viatrac 14 Plus Peripheral Dilation CatheterLIT · Traditional | 01/31/2008SE |
Questions and answers
When was Emboshield NAV6 Embolic Protection System cleared by the FDA?
Emboshield NAV6 Embolic Protection System (K081523) received a 510(k) decision of Substantially Equivalent on September 11, 2008, 101 days after the submission was received.
What is the product code of K081523?
The FDA product code is NTE – Temporary Carotid Catheter For Embolic Capture, a Class II (moderate risk) device regulated under 21 CFR 870.1250.