Emboshield NAV6 Embolic Protection System
FDA 510(k) K141678 · Abbott Vascular
510(k) numberK141678
Submission
- Device name
- Emboshield NAV6 Embolic Protection System
- Applicant
- Abbott Vascular
Santa Clara, CA, US - Received
- June 23, 2014
- Decision date
- July 22, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
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| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresNTE · Traditional | 07/25/2019SE |
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Questions and answers
When was Emboshield NAV6 Embolic Protection System cleared by the FDA?
Emboshield NAV6 Embolic Protection System (K141678) received a 510(k) decision of Substantially Equivalent on July 22, 2014, 29 days after the submission was received.
What is the product code of K141678?
The FDA product code is NTE – Temporary Carotid Catheter For Embolic Capture, a Class II (moderate risk) device regulated under 21 CFR 870.1250.