RX ACCUNET Embolic Protection System
FDA 510(k) K153086 · Abbott Vascular
510(k) numberK153086
Submission
- Device name
- RX ACCUNET Embolic Protection System
- Applicant
- Abbott Vascular
Santa Clara, CA, US - Received
- October 26, 2015
- Decision date
- November 20, 2015
- 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 |
| K143570 | WirionNTE · Traditional | Gardia Medical | 06/04/2015SE |
| K143072 | ENROUTE Transcarotid Neuroprotection SystemNTE · Traditional | Silk Road Medical, Inc. | 02/09/2015SE |
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|---|---|---|
| K220634 | NC TREK NEO Coronary Dilatation CatheterLOX · Traditional | 06/30/2022SE |
| K221057 | Viatrac 14 Plus Peripheral Dilatation CatheterLIT · Special | 05/05/2022SE |
| K201834 | HI-TORQUE PROCEED Guide Wire FamilyDQX · Special | 07/30/2020SE |
| K200144 | HI-TORQUE Steelcore Bare Guide WireDQX · Traditional | 04/08/2020SE |
| K193126 | HI-TORQUE InfilTrac Guide Wire FamilyDQX · Special | 12/11/2019SE |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresNTE · Traditional | 07/25/2019SE |
| K180040 | NC TREK RX Coronary Dilatation Catheter; NC TREK OTW Coronary Dilatation Catheter…LOX · Special | 08/24/2018SE |
| K173795 | HI-TORQUE TurnTrac Guide Wire FamilyDQX · Special | 01/12/2018SE |
| K172394 | Steerable Guide CatheterDRA · Special | 09/06/2017SE |
| K172073 | Hi-Torque Command 18 Guide WireDQX · Special | 08/25/2017SE |
Questions and answers
When was RX ACCUNET Embolic Protection System cleared by the FDA?
RX ACCUNET Embolic Protection System (K153086) received a 510(k) decision of Substantially Equivalent on November 20, 2015, 25 days after the submission was received.
What is the product code of K153086?
The FDA product code is NTE – Temporary Carotid Catheter For Embolic Capture, a Class II (moderate risk) device regulated under 21 CFR 870.1250.