Wirion
FDA 510(k) K200198 · Cardiovascular Systems, Inc.
510(k) numberK200198
Submission
- Device name
- Wirion
- Applicant
- Cardiovascular Systems, Inc.
St.Paul, MN, US - Received
- January 27, 2020
- Decision date
- March 18, 2020
- 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 |
| 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 |
| K143072 | ENROUTE Transcarotid Neuroprotection SystemNTE · Traditional | Silk Road Medical, Inc. | 02/09/2015SE |
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| 510(k) | Device | Decision |
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| K220109 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…MCW · Special | 03/01/2022SE |
| K212725 | ViperCross Support CathetersDQY · Special | 09/24/2021SE |
| K210586 | Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital…MCW · Special | 09/14/2021SE |
| K211240 | ViperCross Support CathetersDQY · Traditional | 08/26/2021SE |
| K211251 | ViperCath XC Peripheral Exchange CatheterDQY · Special | 05/26/2021SE |
| K210282 | WIRION Embolic Protection SystemNTE · Special | 03/03/2021SE |
| K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…MCW · Traditional | 11/19/2020SE |
| K190634 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…MCW · Traditional | 07/02/2019SE |
| K183000 | ViperCath XC Peripheral Exchange CatheterDQY · Traditional | 12/29/2018SE |
| K182397 | Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesMCW · Traditional | 12/13/2018SE |
Questions and answers
When was Wirion cleared by the FDA?
Wirion (K200198) received a 510(k) decision of Substantially Equivalent on March 18, 2020, 51 days after the submission was received.
What is the product code of K200198?
The FDA product code is NTE – Temporary Carotid Catheter For Embolic Capture, a Class II (moderate risk) device regulated under 21 CFR 870.1250.