Wirion
FDA 510(k) K143570 · Gardia Medical
510(k) numberK143570
Submission
- Device name
- Wirion
- Applicant
- Gardia Medical
Caesarea, IL - Received
- December 17, 2014
- Decision date
- June 4, 2015
- 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…
Other 510(k)s with product code NTE
| 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 |
| K143072 | ENROUTE Transcarotid Neuroprotection SystemNTE · Traditional | Silk Road Medical, Inc. | 02/09/2015SE |
More from Silk Road Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K180023 | WirionNTE · Traditional | 03/21/2018SE |
Questions and answers
When was Wirion cleared by the FDA?
Wirion (K143570) received a 510(k) decision of Substantially Equivalent on June 4, 2015, 169 days after the submission was received.
What is the product code of K143570?
The FDA product code is NTE – Temporary Carotid Catheter For Embolic Capture, a Class II (moderate risk) device regulated under 21 CFR 870.1250.